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Wednesday, December 21, 2016
FDA EXTENDS REVIEW OF APPLICATION FOR OCREVUS™ (OCRELIZUMAB)
SOUTHSANFRANCISCO, Calif. – December
20, 2016–Genentech,amemberofthe RocheGroup(SIX:RO,ROG;OTCQX:RHHBY), announced that the U.S. Food and Drug Administration (FDA) has extended the
Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics
Licence Application (BLA) of OCREVUS™(ocrelizumab) to March 28,
2017. The extension is the result of the submission of additional data by
the commercial manufacturing process of OCREVUS, which required additional time
for FDA review. The extension is not related to the efficacy or
safety of OCREVUS.
“We strongly believe in the potential of OCREVUS as a
new therapeutic option for both people with relapsing
forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis
(PPMS)," said Sandra
Horning, M.D., chief medical officer and head of Global Product Development.
“We are working closely with the FDA during their review and are committed to
bringing this innovative medicine to the over 400,000 people with MS in the US
living with this disabling disease as quickly as possible.”
OCREVUS™is the proprietary name submitted
to global regulatory authorities for the investigational medicine ocrelizumab.
OCREVUS is an investigational, 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
The Phase III clinical development program for
OCREVUS (ORCHESTRA) includes three studies: OPERA I, OPERA II and ORATORIO.
OPERA I and OPERA II are identical Phase III, randomized, double-blind,
double-dummy, global multi-center studies that evaluated 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 (i.e.,
relapsing-remitting MS and secondary-progressive MS with relapses). ORATORIO is
a Phase III, randomized, double-blind, global multi-center study that evaluated
the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion
every six months) compared with placebo in 732 people with primary progressive
The most common adverse events associated with
OCREVUS were infusion-related reactions and infections, which were mostly mild
to moderate in severity.
About multiple sclerosis
Multiple sclerosis (MS) is a chronic disease that affects an
estimated 2.3 million people around the world, 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 MS is the most common form of the
disease. Disease activity and progression can occur even when people do not
show signs or symptoms of MS, despite available relapsing MS treatments.
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 one in 10 people with MS are diagnosed with the
primary progressive form of the disease. There are no approved treatments for
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 visithttp://www.gene.com.
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