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Wednesday, March 29, 2017
Press Release: Genentech’s OCREVUS (ocrelizumab) for people with relapsing or primary progressive forms of multiple sclerosis (MS)
The FDA approved Genentech’s OCREVUSTM (ocrelizumab)
for people with relapsing or primary progressive forms of multiple sclerosis
(MS). This is the first and only approved treatment for primary progressive
MS (PPMS), which is one of the most disabling forms of MS.
OCREVUS is an important new
treatment option for people with relapsing forms of multiple sclerosis
(RMS) demonstrating superior efficacy on the three major markers of disease
activity compared with Rebif®.
Key findings from the two Phase III
RMS and one Phase III PPMS studies are included below and additional
information is in the press release. As a reminder, results from these three
Phase III studies were recently published in the January 19, 2017 issue of the New
England Journal of Medicine (NEJM).
·A large Phase III study, OCREVUS significantly slowed
disability progression and reduced signs of disease activity in the brain
compared with placebo in people with PPMS.
·Two large Phase III clinical studies showed that when
compared to interferon beta-1a (Rebif®) in people with RMS, OCREVUS reduced relapses by
nearly half, was better at slowing disability progression and suppressed signs
of disease activity in the brain over two years.
OCREVUS represents a different
scientific approach to treating MS. It is a first-in-class medicine that
targets CD20-positive B cells, a type of immune cell that plays a central role
in the disease.
FDA Approves Genentech’s OCREVUS™
(Ocrelizumab) For Relapsing and Primary Progressive Forms of Multiple Sclerosis
·First and only approved disease-modifying therapy for
primary progressive form of multiple sclerosis (PPMS) – one of the most
disabling forms of multiple sclerosis (MS)
·An important new treatment option for people with relapsing
forms of multiple sclerosis (RMS) demonstrating superior efficacy on the three
major markers of disease activity compared with Rebif®
·A favorable benefit-risk profile demonstrated in three large
Phase III studies with a diverse patient population, including those early in
South San Francisco, CA -- March 28,
2017 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
announced today that the U.S. Food and Drug Administration (FDA) approved
OCREVUS™ (ocrelizumab) as the first and only medicine for both relapsing and
primary progressive forms of multiple sclerosis. The majority of people with MS
have a relapsing form or primary progressive MS at diagnosis.
“The FDA’s approval of OCREVUS is
the beginning of a new era for the MS community and represents a significant
scientific advance with this first-in-class B cell targeted therapy,” said
Sandra Horning, M.D., chief medical officer and head of Global Product
Development. “Until now, no FDA-approved treatment has been available to the
primary progressive MS community, and some people with relapsing forms of MS
continue to experience disease activity and disability progression despite
available therapies. We believe OCREVUS, given every six months, has the
potential to change the disease course for people with MS, and we are committed
to helping those who can benefit gain access to our medicine.”
In two identical RMS Phase III
studies (OPERA I and OPERA II), OCREVUS demonstrated superior efficacy on the
three major markers of disease activity by reducing relapses per year by nearly
half, slowing the worsening of disability and significantly reducing MRI
lesions compared with Rebif® (high-dose interferon beta-1a) over the two-year
controlled treatment period. A similar proportion of people in the OCREVUS
group experienced a low rate of serious adverse events and serious infections
compared with people in the high-dose interferon beta-1a group in the RMS
In a separate PPMS Phase III study
(ORATORIO), OCREVUS was the first and only treatment to significantly slow
disability progression and reduce signs of disease activity in the brain (MRI
lesions) compared with placebo with a median follow-up of three years. A
similar proportion of people in the OCREVUS group experienced adverse events
and a low rate of serious adverse events compared with people in the placebo
group in the PPMS study.
The most common side effects
associated with OCREVUS in all Phase III studies included infusion reactions
and upper respiratory tract infections, which were mostly mild to moderate in
severity. Results from these three Phase III studies were recently published in
the January 19, 2017 issue of the New England Journal of Medicine (NEJM).
“This is an exciting day for
everyone touched by MS, a disease that strikes in the prime of a person’s life
when she or he may be starting a career or family,” said June Halper, MSN,
APN-C, MSCN, FAAN, chief executive officer at the Consortium for MS Centers.
“We have eagerly awaited the FDA approval of OCREVUS because it not only offers
a new, highly efficacious treatment option for people with relapsing multiple
sclerosis, but it is also the first disease-modifying therapy indicated for
primary progressive multiple sclerosis, a highly disabling type of this chronic
disease. For many people living with MS, this FDA approval is a source of
OCREVUS will be available to people
in the U.S. within two weeks. Genentech is committed to helping people access
the medicines they are prescribed and will be offering comprehensive services
for people prescribed OCREVUS to help minimize barriers to access and
reimbursement. Patients can call 1-844-OCREVUS for more information. For people
who qualify, Genentech plans to offer patient assistance programs through
Genentech Access Solutions. More information is also available at (866)
4ACCESS/(866) 422-2377 or http://www.Genentech-Access.com.
The OCREVUS Marketing Authorization
Application (MAA) has also been validated by the European Medicines Agency
(EMA) and is currently under review.
About the OPERA I and OPERA II
studies in relapsing forms of MS
OPERA I and OPERA II are Phase III,
randomized, double-blind, double-dummy, global multi-center studies evaluating
the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion
every six months) compared with interferon beta-1a (44 mcg administered by
subcutaneous injection three times per week) in 1,656 people with relapsing
forms of MS. In these studies, relapsing MS (RMS) was defined as
relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS) with
About the ORATORIO study in primary
ORATORIO is a Phase III, randomized,
double-blind, global multi-center study evaluating the efficacy and safety of
OCREVUS (600 mg administered by intravenous infusion every six months; given as
two 300 mg infusions two weeks apart) compared with placebo in 732 people with
PPMS. The blinded treatment period of the ORATORIO study continued until all
patients had received at least 120 weeks of either OCREVUS or placebo and a
predefined number of confirmed disability progression (CDP) events was reached
overall in the study.
A summary of the data from the OPERA
I, OPERA II and ORATORIO studies that support this approval is below.
Key data in RMS patients treated
with OCREVUS showed:
A 46 percent and 47 percent relative
reduction in the annualized relapse rate (ARR) compared with interferon beta-1a
over the two-year period in OPERA I and OPERA II, respectively (p < 0.0001
and p < 0.0001).
A 40 percent relative risk reduction
in confirmed disability progression (CDP) sustained for 12 weeks compared with
interferon beta-1a in a pooled analysis of OPERA I and OPERA II, as measured by
the Expanded Disability Status Scale (EDSS) (p=0.0006).
A 94 percent and 95 percent relative
reduction in the total number of T1 gadolinium-enhancing lesions compared with
interferon beta-1a in OPERA I and OPERA II, respectively (p < 0.0001 and p
A 77 percent and 83 percent relative
reduction in the total number of new and/or enlarging T2 lesions compared with
interferon beta-1a in OPERA I and OPERA II, respectively (p < 0.0001 and p
Key data in PPMS patients treated
with OCREVUS showed:
A 24 percent relative risk reduction
in CDP sustained for at least 12 weeks compared with placebo, as measured by
the EDSS (p=0.0321).
A -0.39 cm3 mean change in volume of
brain hyperintense T2 lesions compared with a 0.79 cm3 mean change in volume of
placebo-treated patients over 120 weeks (p < 0.0001).
A 25 percent relative risk reduction
in the proportion of patients with 20 percent worsening of the timed 25-foot
walk confirmed at 12 weeks.
The most common side effects
associated with OCREVUS in all Phase III studies were infusion reactions and
upper respiratory tract infections, which were mostly mild to moderate in
severity. Potential serious side effects may include infusion reactions,
infections and malignancies where only routine screening is required based on
age and medical history.
About multiple sclerosis
Multiple sclerosis (MS) is a chronic
disease that affects an estimated 400,000 people in the U.S., for which there
is currently no cure. MS occurs when the immune system abnormally attacks the
insulation and support around nerve cells (myelin sheath) in the brain, spinal
cord and optic nerves, causing inflammation and consequent damage. This damage
can cause a wide range of symptoms, including muscle weakness, fatigue and
difficulty seeing, and may eventually lead to disability. Most people with MS
experience their first symptom between 20 and 40 years of age, making the
disease the leading cause of non-traumatic disability in younger adults.
Relapsing-remitting MS (RRMS) is the
most common form of the disease and is characterized by episodes of new or
worsening signs or symptoms (relapses) followed by periods of recovery.
Approximately 85 percent of people with MS are initially diagnosed with RRMS.
The majority of people who are diagnosed with RRMS will eventually transition
to secondary progressive MS (SPMS), in which they experience steadily worsening
disability over time. Relapsing forms of MS (RMS) include people with RRMS and
people with SPMS who continue to experience relapses. Primary progressive MS
(PPMS) is a debilitating form of the disease marked by steadily worsening
symptoms but typically without distinct relapses or periods of remission.
Approximately 15 percent of people with MS are diagnosed with the primary
progressive form of the disease. Until now, there have been no FDA-approved
treatments for PPMS.
People with all forms of MS
experience disease activity – inflammation in the nervous system and permanent
loss of nerve cells in the brain – even when their clinical symptoms aren’t
apparent or don’t appear to be getting worse. An important goal of treating MS
is to reduce disease activity as soon as possible to slow how quickly a
person’s disability progresses. Despite available disease-modifying treatments
(DMTs), some people with RMS continue to experience disease activity and
About OCREVUS™ (ocrelizumab)
OCREVUS is a humanized monoclonal
antibody designed to selectively target CD20-positive B cells, a specific type
of immune cell thought to be a key contributor to myelin (nerve cell insulation
and support) and axonal (nerve cell) damage. This nerve cell damage can lead to
disability in people with MS. Based on preclinical studies, OCREVUS binds to
CD20 cell surface proteins expressed on certain B cells, but not on stem cells
or plasma cells, and therefore important functions of the immune system may be
OCREVUS is administered by
intravenous infusion every six months. The first dose is given as two 300 mg
infusions given two weeks apart. Subsequent doses are given as single 600 mg
OCREVUS U.S. Indication
OCREVUS is a prescription medicine used
to treat adults with relapsing or primary progressive forms of multiple
It is not known if OCREVUS is safe
or effective in children.
Important Safety Information
Who should not receive OCREVUS?
Do not receive OCREVUS if you are a
patient that has an active hepatitis B virus (HBV) infection. Do not receive
OCREVUS if you are a patient that has had a life threatening allergic reaction
to OCREVUS. Patients should tell their healthcare provider if they have had an
allergic reaction to OCREVUS or any of its ingredients in the past.
What is the most important
information about OCREVUS?
OCREVUS can cause serious side
Infusion Reaction: OCREVUS can cause
infusion reactions that can be serious and require a patient to be
hospitalized. A patient will be monitored during the infusion and for at least
1 hour after each infusion of OCREVUS for signs and symptoms of an infusion
reaction. Patients should tell their healthcare provider or nurse if they get
any of these symptoms: itchy skin, rash, hives, tiredness, coughing or
wheezing, trouble breathing, throat irritation or pain, feeling faint, fever,
redness on the face (flushing), nausea, headache, swelling of the throat,
dizziness, shortness of breath, fatigue, fast heart beat.
These infusion reactions can happen
for up to 24 hours after the infusion. It is important that patients call their
healthcare provider right away if they get any of the signs or symptoms listed
above after each infusion. If a patient gets infusion reactions, the healthcare
provider may need to stop or slow down the rate of the infusion.
OCREVUS increases a patient’s risk
of getting upper respiratory tract infections, lower respiratory tract
infections, skin infections, and herpes infections. Patients should tell their
healthcare provider if they have an infection or have any of the following
signs of infection including fever, chills, a cough that does not go away, or
signs of herpes (such as cold sores, shingles, or genital sores). These signs
can happen during treatment or after a patient has received their last dose of
OCREVUS. If a patient has an active infection, their healthcare provider should
delay treatment with OCREVUS until the infection is gone.
Progressive Multifocal Leukoencephalopathy
(PML): Although no cases have been seen with OCREVUS treatment, PML may happen
with OCREVUS. PML is a rare brain infection that usually leads to death or
severe disability. Patients should tell their healthcare provider right away if
they have any new or worsening neurologic signs or symptoms. These may include
problems with thinking, balance, eyesight, weakness on one side of the body,
strength, or using arms or legs.
Hepatitis B virus (HBV)
reactivation: Before starting treatment with OCREVUS, a patient’s healthcare
provider will do blood tests to check for hepatitis B viral infection. If a
patient has ever had hepatitis B virus infection, the hepatitis B virus may
become active again during or after treatment with OCREVUS. Hepatitis B virus
becoming active again (called reactivation) may cause serious liver problems
including liver failure or death. A healthcare provider will monitor a patient
if they are at risk for hepatitis B virus reactivation during treatment and
after they stop receiving OCREVUS.
Weakened immune system: OCREVUS
taken before or after other medicines that weaken the immune system could
increase a patient’s risk of getting infections.
Before receiving OCREVUS, patients
should tell their healthcare provider about all of their medical conditions,
including if they:
have ever taken, take, or plan to
take medicines that affect the immune system, or other treatments for MS.
have ever had hepatitis B or are a
carrier of the hepatitis B virus.
have had a recent vaccination or are
scheduled to receive any vaccinations. A patient should receive any required
vaccines at least 6 weeks before they start treatment with OCREVUS. A patient
should not receive certain vaccines (called ‘live’ or ‘live attenuated’
vaccines) while being treated with OCREVUS and until their healthcare provider
tells them that their immune system is no longer weakened.
are pregnant, think that they might
be pregnant, or plan to become pregnant. It is not known if OCREVUS will harm
an unborn baby. Patients should use birth control (contraception) during
treatment with OCREVUS and for 6 months after the last infusion of OCREVUS.
are breastfeeding or plan to
breastfeed. It is not known if OCREVUS passes into the breast milk. Patients
should talk to their healthcare provider about the best way to feed their baby
if the patient takes OCREVUS.
What are possible side effects of
OCREVUS may cause serious side
Risk of cancers (malignancies)
including breast cancer. Patients should follow their healthcare provider’s
recommendations about standard screening guidelines for breast cancer.
Most common side effects include
infusion reactions and infections.
These are not all the possible side
effects of OCREVUS.
Patients should call their doctor
for medical advice about side effects. Side effects may also be reported to the
FDA at 1-800-FDA-1088.
For additional safety information,
please see the full Prescribing Information and Medication Guide.
About Genentech in neuroscience
Neuroscience is a major focus of
research and development at Genentech and Roche. The company’s goal is to
develop treatment options based on the biology of the nervous system to help
improve the lives of people with chronic and potentially devastating diseases.
Roche has more than a dozen investigational medicines in clinical development
for diseases that include multiple sclerosis, Alzheimer’s disease, spinal
muscular atrophy, Parkinson’s disease and autism.
Founded 40 years ago, Genentech is a
leading biotechnology company that discovers, develops, manufactures and
commercializes medicines to treat patients with serious or life-threatening
medical conditions. The company, a member of the Roche Group, has headquarters
in South San Francisco, California. For additional information about the
company, please visit http://www.gene.com.
All trademarks used or mentioned in
this release are protected by law. Rebif is a registered trademark of Merck
KGaA and EMD Serono, Inc.