Tuesday, Dec 20, 2016
South San Francisco, CA -- December 20, 2016 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today 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 License Application (BLA) of OCREVUS™ (ocrelizumab) to March 28, 2017. The extension is the result of the submission of additional data by Genentech regarding 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 U.S. living with this disabling disease as quickly as possible.”
OCREVUS™ is the proprietary name submitted to global regulatory authorities for the investigational medicine ocrelizumab.
About OCREVUS ™ (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 preserved.
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 MS (PPMS).
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
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.
RMS is the most common form of the disease. Disease activity and progression can occur even when people do not show signs or symptoms, despite available RMS treatments. 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 PPMS.
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.
About Genentech
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.
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