FDA extends review of application for Ocrevus (ocrelizumab).
Genentech, a member of the Roche Group, 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. It 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.
The 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.
(Source: Business Wire)