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Wednesday, February 17, 2016
NEWS FLASH for people with PPMS--- FDA GRANTS BREAKTHROUGH THERAPY DESIGNATION FOR GENENTECH’S INVESTIGATIONAL MEDICINE OCRELIZUMAB IN PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS
·Ocrelizumab is the first
investigational medicine to receive Breakthrough Therapy Designation in
multiple sclerosis (MS)
·Twelfth Breakthrough Therapy
Designation for Genentech’s portfolio of medicines since 2013
SAN FRANCISCO, Calif. – February 16, 2016 -- Genentech, a member of the Roche group (SIX: RO, ROG;
OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA)
has granted Breakthrough Therapy Designation for the investigational medicine
ocrelizumab (OCREVUSTM) for the treatment of people with primary
progressive multiple sclerosis (PPMS). There are currently no approved
treatments for PPMS, a debilitating form of MS characterized by steadily
worsening symptoms and typically without distinct relapses or periods of
is the first investigational medicine for MS to be granted Breakthrough Therapy
Designation by the FDA,” said Sandra Horning, M.D., chief medical officer and
head of Global Product Development. “With no approved treatments for primary
progressive MS, ocrelizumab has the potential to address an important unmet
need. We are committed to working with the FDA to bring ocrelizumab to people
with primary progressive MS as quickly as possible.”
Therapy Designation is designed to expedite the development and review of
medicines intended to treat serious or life-threatening diseases and to help
ensure people have access to them through FDA approval as soon as possible. The
designation is based on positive results from the pivotal Phase III study
(called ORATORIO), which showed treatment with ocrelizumab significantly reduced
disability progression and other markers of disease activity compared with
placebo. Top-line results were presented at the 31st congress of the European
Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in October
plans to pursue marketing authorization for both PPMS and relapsing multiple
sclerosis (RMS), a more common form of the disease, and will submit data from
three pivotal Phase III studies to the FDA in the first half of 2016.
is the proprietary name submitted to the FDA for the investigational medicine
is an investigational, humanized monoclonal antibody designed to selectively
target CD20-positive B cells. CD20-positive B cells are a specific type of
immune cell thought to be a key contributor to myelin (nerve cell insulation
and support) and axonal (nerve cell) damage, which can result in disability in
people with MS. Based on preclinical studies, ocrelizumab 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 preserved.
addition to ORATORIO, the Phase III clinical development program for
ocrelizumab includes OPERA I and OPERA II, which are randomized, double-blind,
double-dummy, global multi-center studies in people with relapsing forms of MS.
the ORATORIO study in PPMS
is a Phase III, randomized, double-blind, global multi-center study evaluating
the efficacy and safety of ocrelizumab compared with placebo in 732 people with
PPMS. The primary endpoint of the study was
time to onset of confirmed disability progression (CDP) sustained for at least
measures a sustained protocol-defined increase in a patient’s Expanded
Disability Status Scale (EDSS) score. The EDSS is based on a physical and
neurological exam of eight systems throughout the body. The functional systems
include vision, coordination, limb movement, strength, thinking abilities,
bowel and bladder control, sensation and walking ability.
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. Damage to these nerves can cause a wide
range of symptoms, including muscle weakness, fatigue and difficulty seeing,
and may eventually lead to progressive disability.,,
progressive MS (PPMS) is a debilitating form of MS characterized by steadily
worsening symptoms but typically without distinct relapses or periods of
remission.1 Approximately one in 10 people with MS are
diagnosed with the primary progressive form of the disease. There are no
approved treatments for PPMS.
Genentech in neuroscience
is a major focus of research and development at Genentech and Roche.
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, Down syndrome and
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.
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