FDA Extends Review of Ocrevus

The FDA has extended the Prescription Drug User Fee Act date for the Biologics License Application review of Roche’s Ocrevus (ocrelizumab) to March 28, 2017. The extension is the result of the submission of more data from Roche, addressing the commercial manufacturing process of the drug. An analysis of the data will require more review time.

Ocrevus is an investigational, humanized monoclonal antibody designed to selectively target CD20-positive B cells in the body. These immune cells are thought to be key contributors to myelin and axonal damage, which can disable individuals with multiple sclerosis (MS).

A phase 3 clinical development program for Ocrevus consisting of 3 different studies has been launched to evaluate the safety and efficacy of the drug. Thus far, the most common adverse effects associated with Ocrevus are infusion-related reactions and infections, which have been mild-to-moderate in severity.

“We strongly believe in the potential of Ocrevus as a new therapeutic option for both people with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis,” Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development, said in a press release. “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 United States living with this disabling disease as quickly as possible.”