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Roche Ocrelizumab PDUFA

03/28/2017 - 00:00

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Basel, 20 December 2016
FDA extends review of application for OCREVUS™ (ocrelizumab)
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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 28th March 2017. The extension is the result of the submission of additional data by Roche 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 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.
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Source: press release, 12/20/16. http://www.roche.com/investors/updates/inv-update-2016-12-20.htm

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