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Biogen Idec ( BIIB ) said data from a late-stage trial of its potential multiple-sclerosis treatment were positive.
The biopharmaceutical company said results support peginterferon beta-1a as a potential treatment dosed every two weeks or every four weeks for relapsing-remitting multiple sclerosis.
"If approved, peginterferon beta-1a will represent an innovation that offers patients a less frequent dosing schedule of no more than 26 doses annually, as well as a significant reduction in relapses and disability progression," said Gilmore O'Neill, vice president of global neurology late stage clinical development at Biogen.
Biogen said the study's primary endpoint was met for both the two-week and four-week dose regimens. Results showed that peginterferon beta-1a also met the secondary endpoints. It noted that with both dose regimens studied the risk- benefit profile of peginterferon beta-1a appears to be favorable.
The Phase 3 study included more than 1,500 patients with RRMS and was designed to evaluate the efficacy, safety and tolerability of peginterferon beta-1a compared to placebo at one year.
Earlier this month, Biogen said its Phase 3 clinical trial for an ALS treatment didn't meet its primary goals, causing it to discontinue development of the drug for the disease.
And in October, Biogen reported its third-quarter earnings rose 13% as the biopharmaceutical company saw growth of its biggest drug, multiple-sclerosis treatment Avonex, and received a boost from a gain tied to Benlysta.
(END) Dow Jones Newswires
Copyright (c) 2013 Dow Jones & Company, Inc.
January 24, 2012 (Reuters) - Biogen Idec Inc said on Thursday that a late-stage clinical trial of an experimental multiple sclerosis treatment showed it to be safe and effective in cutting the annual rate of relapse in patients with the autoimmune disease.
The injectable treatment, peginterferon beta-1a, also known as Peg-Avonex, is designed to reduce the dosing schedule typical of standard interferon drugs such as Biogen's own Avonex, as it is designed to last longer in the body.
Biogen said the results "support peg-interferon beta-1a as a potential treatment dosed every two weeks or every four weeks for relapsing-remitting multiple sclerosis."
The company said fewer patients relapsed on an every two-week dosing schedule than those on an every four-week schedule in the trial. The study included more than 1,500 patients with relapsing-remitting multiple sclerosis.
Both schedules of use worked at about the same rate to reduce the progression of disability with MS, an autoimmune disease that affects the brain and spinal cord, the company said.
Still, analysts are mainly focused on another multiple sclerosis drug in development by Biogen, BG-12, a pill that some expect could become the leading treatment for the disease.
David Ferreiro, an analyst at Oppenheimer, said in a research report that he expects peak sales of Peg-Avonex of around $830 million a year.
"We see the drug's convenience benefit as modest and expect a diminishing injectables market in the advent of BG-12, an oral with stronger efficacy than injectables," he said.
Biogen said it plans to submit the drug for approval in 2013 and Mark Schoenebaum, a research analyst at ISI Group, said in a note that he expects approval in 2014.
(Reporting By Caroline Humer; Editing by Nick Zieminski)
A new scalp acupuncture clinical case study concludes that acupuncture benefits patients with multiple sclerosis. The study finds that acupuncture relieves the symptoms of multiple sclerosis, increases the patient’s quality of life, slows the progression of physical disability and reduces the frequency of relapses.
Acupuncture for MSScalp acupuncture was applied to several standard scalp zones: motor, sensory, foot motor and sensory, balance, hearing, dizziness, tremor. Acupuncture was applied once a week for the first ten weeks followed by once a month for the next six treatments. The patient in the study had multiple sclerosis (MS) for 20 years.
After the application of 16 acupuncture treatments, standing and walking improved significantly. There was also a marked reduction in numbness and tingling in the limbs. Overall, the patient showed increased energy levels and reported less dizziness. The patient’s condition went into remission after the acupuncture treatments. At the time the research was published, the patient had been in remission for 26 months.
Reference: Hao, Jason Jishun, et al. "Treatment of Multiple Sclerosis With Chinese Scalp Acupuncture." Global Advances in Health and Medicine 2.1 (2013): 8-13.
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Multiple sclerosis is a debilitating and unpredictable disease that often is difficult to diagnose.
Gaithersburg, Maryland-based molecular diagnostic startup DioGenix wants to change all that. The company is conducting a multicenter validation trial to show that its MSPrecise diagnostic technology can look for specific DNA changes in cerebrospinal fluid that ultimately causes auto-immune diseases like multiple sclerosis.
DioGenix is also developing a blood test to look for DNA changes that can portend MS thereby providing an alternative to testing cerebrospinal fluid (CSF) altogether.
President and CEO Larry Tiffany hopes that the test being studied in the validation trial currently will one day become the accepted method for diagnosing the disease because it will prove far superior to current standards of diagnosis, which often lead to false positives.
There really is no one standard test in diagnosing MS and physicians often do a combination of CSF analysis and MRIs as well look at the patient’s clinical history to make a diagnosis.
When analyzing CSF, the clinicians typically look to see if there is an inflammation and whether the body is producing the auto-immune response in the central nervous system. But DioGenix’s MSPrecise test of CSF, by contrast is looking for “specific DNA changes that create that downstream inflammatory process,” Tiffany explained.
Tiffany’s confidence stems from the fact that a previous clinical study showed the company’s test to more accurately diagnose MS than current CSF analysis. Now 150 to 160 patients are being enrolled in a larger validation trial that will help to commercialize the test a couple of years down the road.
Making an accurate and diagnosis of MS, which DioGenix is aiming for, is not simply a matter of helping the patient have a better handle of the disease. It has significant cost implications.
“Every patient wrongly diagnosed with MS is prescribed very expensive therapy and they may be on that therapy for years before it is determined that the person does not have MS,” he said.
MRIs are often used to diagnose the disease and that is problematic for several reasons – one, the MRI of a patient suffering from a severe migraine or Lyme disease looks similar to that of an MS patient. Also, the disease would have to had an impact on the central nervous system to be properly reflected in an MRI. That means a patient has already suffered MS attacks.
But with MSPrecise, there is the potential to put the patient on therapy sooner.
Accessibility in your home starts at your door. Let’s face it – if you cannot easily get in or out the door, you are not going to get very far in life. And life is worth living to the fullest. So, here are a few tips to make coming and going easier.
1. Level Entranceways:
Often the most significant barrier to people with disabilities getting into and out of the home is the entranceway itself. Level or slightly sloped sidewalks and driveways will make access to the home easier whether you have a visual or physical disability or not. If your current home has a step to the front door, can you remove the barrier by changing the landscaping, replacing the step with a gentle slope? Ask a landscaper for ideas.
2. Lower Your Threshold:
Once you get to the door, is there a high threshold that is hard to get over? If the threshold is wood, a quick fix is to sand down the edges on each side (interior and exterior) to create a smooth hump that is easier to slide or roll over, especially when using a wheelchair or scooter. If you need a longer lead way to get over a particularly high threshold, try making a wedge out of a standard piece of lumber (1”x2” or 2”x6” will likely work best) and affix it to the edge of your current door threshold. Ask at the lumber yard if they might cut and sand it down for you.
3. Portable Threshold:
If sanding your door threshold is not possible either due to materials, door design, or because you rent, there is a reasonably low-cost solution — a portable threshold ramp that sits over the existing one. Made of lightweight but sturdy aluminum, the design extends the width of the threshold, making a gentler transition into the house. The advantage of this ramp is that you can fold it up and take it with you when visiting the homes of friends and family whose doorways may provide a challenge. There are several styles, some allow easy access over a step or two. To get an idea what is available go to www.pviramps.com
You might also check with your local building center or NARI (National Association of the Remodeling Industry) office to get a referral to a contractor who specializes in “Universal Design” or “Aging in Place” concepts. Not all ramps work for everyone, so try before you buy (contact your local Senior Center or Independent Living Center to see if they have samples) or get a “satisfaction guaranteed” warranty.
4. Automated Lighting Systems:
Make sure you can see where you are going by installing automatic lighting. Motion sensor lights, readily available at hardware and home improvement stores, can be easily installed with a few simple tools. Once you are inside, sound and voice activated lights can be turned on and off at will as you move through the house. There are also whole-house control systems that allow you to turn lights on and off throughout the house using a master control or a remote; the latter being nice when leaving or returning home in the dark. Look for these at home improvement or lighting stores, or if you have a home security system, ask the company if they have a compatible lighting system.
5. Keyless Entry Lock:
Getting in the door is easier if you do not have to fumble with keys. Today there are many alternatives. You can go hi-tech and punch a code into a keypad or use a one button remote control, similar to the one that opens newer cars. Some can even open the door for you. Ask a locksmith, your security system company, or a home improvement store about the many options available. Or search “keyless locks” on the Web.
If the old-fashioned way is good enough for you, there are key turners with built-up handles that give you greater leverage and make turning keys easier. Search for key turners on websites such as AidsforArthritis.com.
6. Door Closer:
Once you are through the door, does your wheelchair, walker, or scooter make it difficult to reach the door knob and pull the door closed? You could tie a cord or rope around the door knob and fasten it to a hook mounted at a handy place that you can reach. Or, if you prefer something a little nicer looking, an inexpensive solution was designed by a paraplegic that is durable, flexible, and almost invisible. One end of the E-Z Pull Door Closer™ hooks around the door knob, while the other slips into a holder on the door where it is easy to reach and gives you good leverage for pulling the door closed. You can also remove the puller and take it with you to use on other doors while you are away from home. For more information, search www.E-ZPullDoor.com.
If you use a wheelchair or scooter, or even a walker, ramps are much easier to negotiate than stairs. Ramps can be as lovely as a nice deck, built to enhance the look of your home, or as utilitarian and portable as modular aluminum (often a better choice if the home is not your own). They can be expensive, ranging up to $5,000 but if you need one, community agencies will often help you find an affordable way to get one. For assistance, start by calling your local Independent Living Center or United Way (in most areas, just dial 211) and tell them what you are looking for; they will give you referrals to appropriate agencies. You might also call a building contractor that specializes in accessible remodeling for a quote.
8. Vertical Platform Lifts:
If the entry to your home is particularly high, and a long ramp impractical, a vertical platform lift might be a solution. The lift works like an elevator to raise a wheelchair or scooter and a companion, smoothly and effortlessly straight up and down from driveway to entryway, patio to porch, etc, from four feet to up to 14 feet in height. A lift, powered by battery or household current, is durable indoors or outdoors for even the harshest winter weather, and really levels the playing field for someone living in a multi-level situation. To learn more about vertical platforms visit www.Bruno.com.
9. Outdoor Stair Lift:
If you are still mobile but need assistance getting up the stairs from driveway to porch, deck, or raised entry way, an outdoor stair lift may be the answer. Just sit in the seat and let it raise you to the next level. This is another option that may be viewed at www.Bruno.com.
10. Electric Door Openers:
For maximum independence, you can install an electric door opener. These are on the expensive side, however if you are unable to turn keys or open or close doors, an electric door opener opens the door for you with a remote control or keypad. And when you are inside, you can open the door remotely, “buzzing” in your guests, just like you might at an apartment entry. These devices can even be operated by pressure sensitive mats or whisper devices for the severely disabled. For more information search www.OpenSesameDoor.com.
Shelley Peterman-Schwarz began her work at www.MeetingLifesChallenges.com to share what she has learned about how to live a full life despite the challenges of living with a chronic disabling illness. The website contains her blog “What I learn about LIVING from my chronic illness” along with videos and DVDs where Shelley welcomes you into her home and shares her everyday tips and strategies for living. It also includes her articles, product recommendations, and the signup for her free monthly newsletter. Shelley’s newest book in the Tips for Making Life Easier™ series, is Home Accessibility: 300 Tips for Making Life Easier™, affordable solutions to make your home safer and more accessible, was published in January 2012. She can be reached by email at: Shelley@MakingLifeEasier.com
'Stu's Views and MS News' wants to let you know
about a new co-pay program launched by EMD Serono, Inc. and Pfizer. Although
insurers are paying for an increasing share of prescription drug costs,
patients are still paying more of these overall costs. In fact, doubling
patients’ co-payments for drugs can reduce their use of medications by 25 to 45
It is with this environment in mind
that EMD Serono, Inc. and Pfizer launched today a $0 co-pay program for Rebif®
(interferon beta-1a) as part of its MS LifeLines Access Made Simple
program. Any eligible person with relapsing multiple sclerosis (MS)
starting Rebif therapy on or after January 22 will have this program available
to them with no additional paperwork. People currently on Rebif therapy can
call MS LifeLines at 1-877-447-3243 to determine eligibility.
Access Made Simple is an access program that provides eligible patients with
co-pay and free drug assistance intended to help patients with the
affordability and access to Rebif.
is open to US residents who have a relapsing form of MS and are starting Rebif
therapy or presently taking Rebif therapy. Patients covered by federal and
state healthcare programs are not eligible for assistance. Eligible people
taking Rebif who are currently enrolled in the MS LifeLines Access Made Simple
program will be automatically enrolled in the $0 co-pay program by April 1,
and Pfizer are committed to helping people living with relapsing MS start and
stay on Rebif as prescribed. The introduction of the $0 co-pay program
signifies the companies’ commitment to the MS community and dedication to
providing even more affordable access to therapy.
For more information about the MS LifeLines
Access Made Simple $0 co-pay program, call 1-877-447-3243 to speak with a
Reimbursement Case Specialist. You can also visit MSLifeLines.com to learn
At the heart
of the MS LifeLines network is its call center, which marked a milestone in 2010
by answering one million in-bound calls from the MS community. The call center
includes patient enrollment specialists, patient support specialists, nurse
support specialists and reimbursement specialists. Whenever someone in the MS
community needs to speak with a live person, support is available toll-free at
1-877-447-3243. The MS community can also visit MS LifeLines online at www.mslifelines.com.
Rebif® (interferon beta-1a)
Rebif is used
to treat relapsing forms of MS to decrease the frequency of relapses and delay
the occurrence of some of the physical disability that is common in people with
MS. Rebif is not approved for treatment of chronic progressive MS. Rebif is
available in 22 mcg and 44 mcg prefilled, preassembled syringes and a titration
not cure MS but it has been shown to decrease the number of flare-ups and slow
the occurrence of some of the physical disability that is common in people with
MS. Rebif can cause serious side effects, so before taking Rebif,
patients should talk with their doctor about the possible benefits of Rebif and
its possible side effects.
serious side effects of Rebif include depression, liver problems, risk to
pregnancy, allergic reactions and injection-site problems. Patients who have
had an allergic reaction such as difficulty breathing, flushing or hives to
another interferon beta or to human albumin should not take Rebif.
Rebif, patients should tell their doctor if they have a history of depression,
anxiety, trouble sleeping, liver disease, thyroid problems, blood cell count or
bleeding problems, epilepsy, or are planning to become pregnant. Patients
should tell their doctor about all medicines they take, including prescription
and non-prescription medicines, vitamins and herbal supplements. Rebif and
other medicines may affect each other causing serious side effects. Patients
should talk to their doctor before taking any new medicines.
effects of Rebif include flu-like symptoms (fever, chills, sweating, muscle
aches and tiredness), injection-site reactions, depression and anxiety, liver
problems, abdominal pain, blood problems, thyroid problems and severe allergic
reactions. Patients should let their doctor know if they have any of these
symptoms or feel sad, tired, hot or cold, or experience hives, rashes,
bruising, yellowing of the skin, or a change in body weight (gain or loss).
information is not intended to replace discussions with a doctor. For additional
information about Rebif, please consult the Prescribing Information and Medication Guide at www.rebif.com and talk to a doctor. Information is
also available at www.mslifelines.com or call toll-free 1-877-44-REBIF
(1-877-447-3243). Rebif is available by prescription only.
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WHEN mountain climber Carole Hassall was diagnosed with multiple sclerosis she feared her days of enjoying the great outdoors were over.
But the 55-year-old has discovered a new lease of life thanks to her hand-crank tricycle, which has allowed her to conquer hills again despite losing much of the use of her legs.
Carole Hassall has been diagnosed with multiple sclerosis
Carole, above, is now planning to help other MS sufferers by organising a ride across the Peak District in aid of the MS Society.
The mother-of-one hopes that by completing the 14-mile ride she will prove that people can bounce back from MS and enjoy their life despite their disability.
Carole, of High Street, Ipstones, was first struck down with the disease in April 2010, as she was preparing for a trip to Snowdonia with her husband Phil.
The couple's great love was climbing mountains, and they had previously explored peaks across Britain, as well as the Pyrenees.
Carole said: "I was packing for the trip when I just collapsed. My left side went into spasms and went rigid. I was like that for about half-an-hour. By the time the ambulance arrived I was able to move again, but over the next few days it happened again.
"The main problem now is I can't walk very far. I can walk about 80 metres, but that takes a long time, and I feel very tired afterwards. Most of the time I am confined to a wheelchair.
"At first I was diagnosed with neurosarcoidosis, and I was told that I could get up to 60 per cent of my movement back with treatment. But when I didn't get any better I knew that it must be something else."
Carole's disability has not stopped her from working, although she has had to shift from a receptionist role at NHS North Staffordshire to a job in administration.
But it was only after friends introduced her to the hand-crank trikes that Carole realised that she could rediscover her passion for adventure.
Carole said: "I loved the challenge of climbing a mountain, and the sense of achievementwhen you get to the top. It's just a lot of fun.
"I've always been an optimist, I'm determined to make the best of any situation. So after feeling sorry for myself for a while, I decided to try and get active again.
"As soon as I tried the hand-trike I just loved it. It meant I could go to the places I went before. It did take a bit of getting used to, but climbing mountains involved a lot of scrambling, so I did have quite good upper body strength anyway.
"After attending a 'newly diagnosed' day organised by the MS Society I saw what good work they did, and I decided I wanted to do something to help them. That's when I came up with the idea for the ride."
Carole and Phil will be joined by around 15 friends and family on the trek from Parsley Hay to Ashbourne in the Peak District, along the Tissington Trail on March 30.
The couple are also organising a fund-raising concert at Ipstones Village Hall on April 13, and hope to raise around £1,000 for the charity.
Phil said he was very proud of his wife. The 59-year-old graphic designer added: "Carole has always been very strong and positive. Since being diagnosed she has had her moments, obviously, but I don't think I would have been able to cope with it as well as she did. Climbing was our great love, and it was very sad finding out that Carole wouldn't be able to do it again. But the hand trike really has given her a new lease of life."
(For the American's reading this article and thinking of words like organising being misspelled,,, "BZZZ" - wrong - this is how it is spelled in the UK, and other places ...)
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Multiple sclerosis, or MS, is a disease of the nervous system that can affect the brain and spinal cord. MS symptoms are caused by the progressive loss of myelin, the outer protective lining of nerve fibers. Myelin is like the coating around an electrical wire: Without enough myelin, nerve signals have trouble passing through the nerves. The full cause of MS is not completely understood, but it's partly due to the body's immune system mistakenly attacking myelin cells. That's why multiple sclerosis is called an autoimmune disease.
Anyone Can Get MS
In the United States, MS affects approximately 1 in 700 to 1 in 1,000 people. Over two million people worldwide are affected by MS. “The incidence varies widely," says John Wilson, MD, a neurologist at Gottlieb Memorial Hospital in Maywood, Ill., part of the Loyola University Health System. "It is a disease that is more common the farther north from the equator one gets. It tends to be more common in women than men and to occur in people between 20 and 40, but people any age can get it.” According to the National Multiple Sclerosis Society, about 200 people are diagnosed with MS every week.
MS Causes and Triggers Vary
Doctors think MS is caused by a combination of factors. "Part of the cause is genetic, but there must also be some environmental factors that trigger the disease," says Matthew McCoyd, MD, a neurologist, assistant professor, and associate neurology residency program director with the Loyola University Health System in Illinois. “Possible MS triggers may include things like decreased sunlight, vitamin D deficiency, or viral infections.” The genes you’re born with may increase your risk for multiple sclerosis, but there is no evidence that MS is directly passed down through families.
Some MS Symptoms Are Common, Some Are Not
"Commonly, multiple sclerosis can cause problems with vision, including sudden loss of vision in one eye or, rarely, both eyes; double vision; blurred vision; severe dizziness; imbalance; numbness; weakness; muscle spasms; tremors; speech problems; depression; and facial pain,” says Dr. Wilson. “While facial pain is a symptom of MS, headache is almost never caused by MS." Other MS symptoms include fatigue and mental fogginess or confusion. The most important thing to know about these symptoms is that they come and go unpredictably.
MS Can Flare and Relapse
MS flares may be old symptoms, such as fatigue, numbness, or tingling, which start up when someone with MS is overtired or perhaps fighting off an infection. "A relapse occurs when the disease acts up and causes new damage to the nervous system," says Dr. McCoyd. "Relapse symptoms that last for more than a full day and include symptoms that are disabling are usually treated." After treatment, these symptoms may go away completely, a period known as remission. New medications to treat MS are aimed at keeping people in remission for longer periods of time. Flare symptoms that have occurred before and are not disabling usually don’t require any treatment.
There Are Four Types of MS
"There is relapsing-remitting, the most common type; relapsing-progressive; secondary-progressive; and primary-progressive MS," explains Wilson. People who have the relapsing-remitting type of MS have periods of remission between attacks, when the disease does not progress. About 85 percent of people have this type of multiple sclerosis. The progressive types of MS are more difficult to manage and treat because they have few or no periods of remission between attacks. These types of MS are rare.
MS Is Treatable
There was a time when doctors could only treat severe MS symptoms with steroids, and then hope for the best. Now, however, there are promising medical advances. "If I have to say one thing about MS, it is that it is treatable,” says Wilson. “Gone are the days when we had to stand by and watch the disease progress without being able to treat it. There are a number of medications available, and more in the pipeline. Today's medications are effective in reducing the symptoms and the progression of the disease."
MS Medications Are Evolving
Steroid drugs are still used to treat MS relapse symptoms, but the big advance in MS treatment over the past 20 years has been a category of medication called disease-modifying drugs. These drugs are started as soon as possible after diagnosis to prevent MS progression. Medications called interferons, given by injection, prevent immune cells from getting into the brain and the spinal cord. Other medications are given by periodic intravenous infusion, and some can be taken by mouth. Newer drugs are becoming available that have fewer side effects, can be taken by mouth, and may need to be given only a few times a year. In 2012, for example, great advancements were made in the use of nanotechnology for treating multiple sclerosis.
The Prognosis for People With MS Is Improving
Early treatment with disease-modifying drugs has changed the prognosis of multiple sclerosis. "Except for rare cases of progressive disease, data from the past 20 years now show that people with MS can expect to live full and normal lives with no drop in life expectancy," says McCoyd. The majority of people with MS do not become severely disabled. Although some people will need the help of a cane or wheelchair because of fatigue or weakness, about two-thirds of people with MS never lose their ability to walk.
You Can Live a Full Life With MS
"Generally, eating healthy foods and exercise help," says Wilson. "The most common triggers for symptoms are infections, heat, and high stress. Avoiding these can reduce flare-ups in many people." Although most people with MS do not become severely disabled, they do have bothersome and unpredictable MS symptoms, and they may tire easily. They need to know their limitations and work closely with their MS treatment team. Women with MS can get pregnant and often go into remission during pregnancy.
There Is Hope for a Cure
Although there is still no cure for MS, treatment and management have come a long way. "There are several new drugs that will be approved this year alone," says McCoyd. New drugs have also been approved to reduce symptoms of the rarer relapsing forms of MS. According to the Multiple Sclerosis Society, advances in the treatment and understanding of MS are being made every year, and the possibility that future research will finally find the cure for multiple sclerosis is very encouraging. Meanwhile, research into the use of stem cells to cure MS is ongoing.
- Marketing Applications Supported by Risk Stratification Data -
WESTON, Mass. & DUBLIN--(BUSINESS WIRE)--Jan. 16, 2013-- Today Biogen Idec (NASDAQ: BIIB) and ElanCorporation, plc (NYSE: ELN) announced that they have submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) requesting updates to the TYSABRI® (natalizumab) labels. The applications request an expanded indication that would include first-line use for people living with certain relapsing forms of multiple sclerosis (MS) who have tested negative for antibodies to the JC virus (JCV). A formal assessment of both applications is ongoing.
These submissions are supported by risk stratification data and a risk algorithm that enables physicians and individuals living with MS to make informed decisions when considering treatment with TYSABRI. If approved, a first-line label will allow all appropriate anti-JCV antibody negative patients to consider TYSABRI early in the course of treatment, regardless of the level of disease activity or prior treatment history. TYSABRI is a highly efficacious treatment that has been shown to slow disability progression by 42 – 54 percent and reduce annualized relapse rates by 68 percent.
“Our anti-JCV antibody test, STRATIFY JCV®, helps to determine the most appropriate patients for TYSABRI and the data collected to date supports our recent filing for first-line use,” saidAlfred Sandrock, M.D., Ph.D., senior vice president, Development Sciences and Chief Medical Officer, Biogen Idec. “Many appropriate patients are already benefiting from TYSABRI. A first line approval would allow people with MS access to a highly efficacious treatment earlier in the course of the disease, potentially leading to better outcomes. This is an important consideration for people with MS who may want or need more efficacy.”
Currently in the U.S., due to an increased risk of an opportunistic viral infection, progressive multifocal leukoencephalopathy (PML), TYSABRI is generally recommended for people living with relapsing forms of MS whose disease is not responding to, or who are unable to tolerate, an alternative therapy regardless of JCV status. In the EU, TYSABRI is approved for highly active relapsing-remitting MS (RRMS) in adult patients who have failed to respond to beta interferons or have rapidly evolving, severe RRMS.
“TYSABRI is an important treatment option for thousands of people living with MS,” said Hans Peter Hasler, chief operating officer, Elan Corporation, plc. “We are excited about these filings and the potential to make TYSABRI available as a treatment option for more individuals early in the course of their disease.”