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Saturday, September 24, 2022

Novartis to Petition U.S. Supreme Court to Uphold Gilenya Patent

 Novartis said it will petition the U.S. Supreme Court to uphold a patent that protects the dosing regimen of Gilenya (fingolimod) that’s approved for relapsing forms of multiple sclerosis (MS).

The original patent was not set to expire until the end of 2027, which meant generic versions wouldn’t be able to reach the market until that date. But a recent court ruling deemed the patent invalid, which would allow generics to be immediately launched.

The patent has been previously challenged by companies wishing to market Gilenya generics, most recently by HEC Pharma in 2020. In a hearing, the U.S. District Court for the District of Delaware ruled in Novartis’s favor to uphold the patent’s validity.

It was again upheld in a three-judge panel from the U.S. Court of Appeals for the Federal Circuit (CAFC) in January and an injunction was imposed on HEC, preventing it from mounting more legal challenges until the patent expired.


However, a modified CAFC panel reversed that original decision in June and found the patent to be invalid following HEC’s request for another hearing.

Now, Novartis will ask the Supreme Court to review that decision.

“Novartis intends to vigorously defend the validity of the patent and is considering all available options, including current plans to seek review of this decision by petition to the US Supreme Court, a process which may take several months to determine if the petition will be granted,” the company said in a press release.

Gilenya was approved in the U.S. in 2010 for treating adults with relapsing forms of MS, including clinically isolated syndromerelapsing-remitting MS, and active secondary progressive MS. The approval was expanded in 2018 to include children and adolescents ages 10 and older.

The approved dosing regimen, protected under the patent, is a 0.5 mg dose taken orally once a day.

Generic medications contain the same active ingredients and have the same effects on the body as their brand name reference product. Introducing generics into the market generally drives drug prices down by generating competition.

Generics are approved based on abbreviated new drug applications wherein proof must be provided that the therapy is equivalent to the reference medication, but preclinical and clinical data to establish its safety and effectiveness are generally not required.

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FDA puts brakes on Sanofi's $3.7B multiple sclerosis bet, imposing partial hold, over liver injuries

 Paul Hudson

The $3.7 billion centerpiece of Paul Hudson’s R&D strategy for Sanofi has hit a setback. Seeing cases of drug-induced liver injury, the FDA has slapped a partial clinical hold on phase 3 trials of the candidate, raising still more doubts about the merits of Sanofi’s Principia Biopharma takeover.

Sanofi struck a deal to buy Principia in 2020, with Hudson brushing off concerns about the limitations of midphase data on tolebrutinib and broader doubts about the efficacy of BTK inhibitors in autoimmune diseases to make the asset a key part of his attempt to kick-start the R&D engine after taking over as CEO. Now, the FDA has tapped the brakes on Sanofi’s push to get the molecule to market. 

The action affects phase 3 clinical trials of the Bruton’s tyrosine kinase inhibitor in multiple sclerosis and myasthenia gravis. Under the terms of the partial FDA clinical hold, enrollment at U.S. sites is stopped and dosing is suspended in existing subjects who have been in the study for fewer than 60 days. Sanofi can keep dosing participants who have completed at least 60 days in the study.

Officials at the FDA imposed the restrictions in response to “a limited number of cases of drug-induced liver injury,” Sanofi said. According to the company, most patients had “concurrent complications known historically to predispose to drug-induced liver injury,” and the elevated laboratory values were reversible after they stopped taking the treatment.

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Saturday, September 10, 2022

How Age Affects Multiple Sclerosis Symptoms and Progression

 While age at diagnosis may influence the rate of MS progression, it appears not to be the only factor.

By Connie Brichford          Medically Reviewed by Jason Paul Chua, MD, PhD



Most people with multiple sclerosis (MS) are diagnosed between age 20 and 50, though it can occur in children as well as in older adults, according to the National Multiple Sclerosis Society (NMSS).

About 85 percent of people diagnosed with MS are initially diagnosed with the relapsing form of the condition, usually referred to as relapsing-remitting MS, which is characterized by periods of active symptoms — sometimes called flares or exacerbations — alternating with periods of less-severe symptoms.

Eventually, as many as 90 percent of these people reach a stage known as secondary-progressive MS (SPMS), in which symptoms gradually worsen and a person experiences increasing levels of disability. That might include more difficulty walking, loss of stamina, and cognitive problems. Some people with SPMS continue to experience relapses, but many don’t.

The transition from relapsing-remitting MS to secondary-progressive MS appears to be age dependent, with the forties being the most common period to experience it, according to a review article published in April 2021 in Frontiers in Neurology.

However, the authors of the review say, because there is no consensus among experts regarding any specific diagnostic criteria for disability progression, nor are there any definitive biomarkers of progression, a diagnosis of SPMS can only be retrospective (after the fact). That limits doctors' ability to treat MS progression in its early stages.

Age at Diagnosis and MS Progression

The thinking used to be that MS progressed more quickly in people diagnosed at an older age. Indeed, research published in the Journal of Neurology, Neurosurgery & Psychiatry found that children diagnosed with MS took longer to develop secondary-progressive disease (32 years) than adults diagnosed with MS (18 years), and they also took longer to reach disability milestones. 

But the study authors note that those diagnosed as children hit disability milestones at a younger age and therefore could be considered to have a poorer prognosis.

Helen Tremlett, PhD, Canada research chair in neuroepidemiology and multiple sclerosis and a professor at the University of British Columbia in Vancouver, says that her work since 2006 has shown that late-onset MS does not necessarily mean “a worse outcome for the patient.”

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Friday, September 9, 2022

Mindfulness Training Can Help People With Chronic Pain Reduce Their Pain and Dosage of Opioids

 In the largest trial of its kind to date, researchers found mindfulness training reduced pain, opioid dosing, and depression for chronic pain patients.

By Kaitlin Sullivan  - March 7, 2022


Another massive study has shown the power mindfulness-based therapy can have on the brain. 

A randomized clinical trial by Utah researchers compared the efficacy of mindfulness-based therapy with cognitive behavioral therapy (CBT) in reducing both opioid use and pain in chronic pain patients. 

The trial, published in JAMA Internal Medicine in February 2022, was the latest in a series of studies that use mindfulness-based techniques to reduce pain and opioid use in people with chronic pain. The lead study author, Eric Garland, PhD, a licensed clinical social worker, distinguished professor, and the director of the Center on Mindfulness and Integrative Health Intervention Development at the University of Utah in Salt Lake City, designed the Mindfulness-Oriented Recovery Enhancement (MORE) approach. It combines mindfulness training, changes to the course of negative thoughts, relearning how to appreciate positive experiences, and positive psychology, which encourages people to focus on their strengths rather than weaknesses. 

The randomized clinical trial included 250 adults with chronic pain who were misusing the opioids they were prescribed to treat their pain. Half met criteria for opioid use disorder (OUD) at the time they were enrolled in the trial. Roughly half the patients underwent group mindfulness training for eight weeks using MORE. The control group received standard CBT in a group setting. 

The researchers encouraged the patients to do what was right for them and did not force anyone to wean themselves off medication. For patients who wanted or needed to remain on opioids, MORE helped them reduce their risk of misuse and relieved pain. 

Opioid misuse decreased by an average of 45 percent in the MORE group, double that of the CBT group. More than 35 percent of people in the MORE group cut their opioid use by at least half. The people in the MORE group also reported less pain, opioid cravings, and emotional distress, even though they were taking fewer pain pills. The effects lasted at least until the researchers’ nine-month follow-up period. And although the effects appeared to plateau between six and nine months for the MORE group, the effects of CBT actually waned in the control group. 

“It’s difficult to make blanket statements about chronic pain since it’s so different in everyone, but there seems to be a way of modulating how one’s relationship with pain modulates the amount of craving they have for a drug,” says Fadel Zeidan, PhD, an associate professor of anesthesiology at the University of California in San Diego and the director of the Pain, Health, and Mindfulness Lab, who was not involved in the new research. 

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Acupuncture to Help Chronic Pain

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Acupuncture involves using thin needles to puncture the skin at specific points on the body. This technique is a practice used in traditional Chinese medicine (TCM), which has been around for thousands of years.


How It Works
Needles are placed on the skin to activate qi, which in TCM is considered the life force, the energy of the body that helps keep you well. In Western biomedical words, the points where the needles are placed are believed to activate the central nervous system to release chemicals throughout the body, or reduce this activity, that can help with healing.


In China, acupuncture is often used as a go-to treatment for everything from asthma to diabetes, but in the United States, it is more often used as a complementary treatment alongside other treatments or drugs for conditions like low back pain, joint pain, and headaches, and sometimes to help ease nausea and vomiting.


Chronic Pain Symptom Relief
In a meta-analysis of studies published in The Journal of Pain, researchers at the Acupuncture Trialists' 

Collaboration found:

Acupuncture is effective for the treatment of chronic pain.

The effects of acupuncture persist over time.
The benefits of acupuncture cannot be explained solely by the placebo effect.
In a series of papers about chronic pain published in The Lancet, authors analyzed reviews of studies about chronic pain and treatment approaches. They included research that found mixed evidence regarding whether active acupuncture is more effective than sham acupuncture. Sham acupuncture is the research study approach used as a control acupuncture group; the skin isn’t penetrated, and instead, a device places pressure on the skin or needles are placed outside of the common points used for treatment.

 The researchers summarized the inherent challenges of performing truly controlled acupuncture studies and forming general conclusions about acupuncture's effectiveness because of, for example, the high variety of unique characteristics in patients, the variety of types of acupuncture and point prescriptions, and the variety of durations of treatments used in clinical practice.

Researchers further reported in The Journal of Pain that for those with nonspecific musculoskeletal pain, osteoarthritis (OA), headache, or shoulder pain, acupuncture relieved pain compared with sham and no-acupuncture control groups. Additionally, they noted that treatment effects might persist up to a year. However, the researchers stated that the effect is highly dependent on the choice of control treatment

Monday, August 29, 2022

The story of a Husband and Wife, with Multiple Sclerosis

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A personal story about Dan and Jennifer Digmann, both of whom, have MS

There’s two of us, so let’s start with our multiple sclerosis elevator speeches:


JENNIFER

“I was diagnosed with MS on November 14, 1997, eight days after my 23rd birthday. 23 years old, single and I had a chronic disease of the central nervous system for which there is no cure. I had just graduated from the University of Michigan-Flint and had started my first “big girl” job in Detroit. But only five years after my diagnosis, I was no longer able to work or walk, and I was back to living with my parents.”


DAN

“I actually was diagnosed on Valentine’s Day 2000. I was 27 years old and had just started my new job as a writer at Central Michigan University. Even though my hands and feet always feel numb, my disease has stayed somewhat under control. But as you can see between Jennifer and me, symptoms of MS vary from person to person.”


Sounds like a love story in the making, right? For real.

As fate would have it, we met at a National Multiple Sclerosis Society event in 2002 (not sure if it was coincidence that it was called “Finding Your Buried Treasure!” We fell in love and were married in 2005.

This MS life together and serving as each other’s primary caregiver has had more than its share of anxious moments, frustrations and tears. This includes everything from Dan going to the ER because his bronchitis amplified his MS symptoms, Jennifer occasionally needing help feeding herself, or us getting stranded in Virginia because her wheelchair was too big for the airplane cargo ramp.

But through our combined 40+ years living with this chronic disease, we found the keys to our MS happiness were to keep moving forward, stay connected and be your own best advocate.


Don’t look back. You’re not going that way.

We could consume our lives looking back at what we’ve lost because of our MS. For example Jennifer hasn’t been able to walk in over 16 years, and Dan can no longer competitively run in 5K races. Sure, we can pause and reflect on what those times were like, but it’s wasted energy and that keeps us from realizing the new adventures and opportunities of each new day. Like when we discovered a barrier-free boat and went fishing last summer or braved the freezing temperatures and went camping in an accessible cabin late last fall. And now we are looking forward to what this new year has in store for us, like going to Comerica Park for a Detroit Tigers game and raising MS awareness in Motown through MS4MS!


Reach out. Someone needs you today.

We didn’t want to fall trap to the self-imposed side effects of MS. It can be a very isolating disease, but this is the one area where we’ve pushed to stay connected to others and make new connections daily. After all, how would we ever have found our buried treasure? 🙂 Whether it’s calling a friend, commenting on an MS community social media post or sending a letter (how old school, right?), these interactions interrupt any perceived feelings of being alone. And these connections help us as all to move forward.


No one knows your story better than you.

Silence is less than golden when you’re living with MS. Every form of the disease is different, so how else will people know what we need if we don’t speak up for ourselves? This is why we have dedicated our lives to MS activism and annually participate in MS fundraising events and regularly connect with our legislators to encourage support for programs that benefit us and members of the MS community. This includes traveling to Michigan’s capitol and advocating for the MI Choice Medicaid Waiver which provides Jennifer’s caregivers while Dan works during the day and going to Washington, D.C., to encourage legislation that provides for further MS research. It’s all about being your own best advocate.

We never asked to get diagnosed with MS. We truly had no choice in the matter. But what we’ve learned is that it’s up to us how we choose to live with this disease. We both chose to marry another person who is living with this progressive disease, and we continue to live our best life together. Sure, we have daily MS challenges, but fighting MS is a total team effort.


We surround ourselves with a strong team of family, friends, caregivers and medical professionals, but, fortunate for us, we have a co-captain who totally gets MS and is our respective biggest fan.


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Written by
Dan and Jennifer Digmann

 

Edited by
Garrett Owen and Emily Garczynski

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Numb Feet: Is It MS? Or Something Else?

 

There are many causes of foot numbness, whether or not you have MS. If you know you have MS, your disease is the most likely culprit, but there are other potential causes.   Shutterstock



Numbness of the face, body, or extremities (arms and legs) is one of the most common symptoms of multiple scelerosis (MS), and can occur very early in the course of the disease, according to the National Multiple Sclerosis Society.

But numb or tingling feet can be caused by a number of conditions other than MS, some of which can be treated or reversed. This means that while MS might be behind what’s happening in your feet, you shouldn’t assume this is the case. And sometimes, numb feet can be a sign of an undiagnosed condition — like diabetes or a nutrient deficiency — that requires urgent treatment.

Here are some of the most common causes of numb or tingling feet, along with some of the signs that may point toward one condition or another. It’s important to note that only a doctor can determine what’s causing your foot symptoms, and you should report any changes in sensation in your feet (or anywhere else in your body) to your neurologist or primary care doctor.


MS

If you’ve already been diagnosed with MS, odds are that’s what is causing your feet to feel numb, unless you’re showing obvious signs of another condition.

“It would be human nature for someone with MS to say, ‘My feet are numb. It must be the MS,’” says Michael Polydefkis, MD, a neurologist and peripheral neuropathy specialist at Johns Hopkins Bayview Medical Center in Baltimore. “And playing the odds, they might be right most of the time.”

If your foot numbness or tingling is caused by MS, the sensation will often spread up your leg over days to weeks as part of a relapse, according to Nancy Nealon, MD, a neurologist at Weill Cornell Medicine in New York City.

Another telltale sign that MS is likely the culprit is if you experience weakness in the same area as your numbness or in your opposite foot. “People with MS may have more weakness on one side and more numbness on the other,” Dr. Nealon notes.

To help determine whether your foot symptoms are caused by MS, Nealon says, your neurologist will most likely give you a physical examination that measures your response to vibration and temperature changes in the area. Your doctor will also want to check your reflexes, which are more likely to be affected by MS than other potential causes of numb feet.

Certain symptoms may lead your doctor to consider conditions other than MS. “Often it’s the localization of where the discomfort is” that points toward something else, says Nealon, since MS rarely causes sensation changes in just one area of the foot, such as the heel or big toe.

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Wednesday, August 17, 2022

Multiple Sclerosis Activists Play Key Role in Passage of Meaningful Prescription Drug and Health Insurance Legislation

 

On August 12, the U.S. House voted to pass the Inflation Reduction Act, following the U.S. Senate’s passage of the legislation, which includes meaningful provisions to lower the cost of prescription drugs and health insurance. The bill now moves to the President’s desk where it is expected to be signed into law. 

“This important milestone in legislation would not have happened without those affected by MS using their voices to create change,” said Cyndi Zagieboylo, President and CEO of the National Multiple Sclerosis Society. “People with MS have long told us they struggle to afford their life changing MS medications, and together we have worked tirelessly to find solutions to the high cost of MS medications.” The current median annual price of a brand MS disease-modifying therapy (DMT) is nearly $94,000, with prices continuing to rise since 1997. 

MS Activists working with the National MS Society played a critical role in the passage of these provisions. Together, MS Activists held more than 2,000 legislative meetings since 2016, sent over 10,000 emails to Capitol Hill, shared hundreds of videos and tweets, and shared personal stories through OpEds, articles, testimony and commercials. 

Judy Wilson, an MS Activist who lives with MS in Arizona recently shared with reporters, “When I went on Medicare, I could not afford the over $7,000 a year for my MS DMT and had to stop my medication. My decision was based on money, not medicine. The proposals will help me tremendously. These policies will immediately improve my quality of life and my health.”

The following drug pricing provisions that will benefit people with MS and others on prescription medications include:  

  • Bringing down what people pay for their medications: Implementing a $2,000 out-of-pocket cap on drug costs in Medicare Part D and a “smoothing mechanism” so that people in Medicare can spread their costs evenly over the course of the year. 
  • Curbing drug price increases: Limiting Medicare drug price increases by enacting rebates if prices rise faster than inflation. 
  • Negotiating prices to bring down cost: Allowing Medicare to negotiate prices for a select number of drugs that have been on the market for a long time.
  • Bringing down the cost of insurance: Allowing an extension of previously-passed tax credits to help make coverage more affordable for those who purchase coverage via the Exchanges.

Learn more about the implementation timeline and impact this law will have on people living with MS.

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