Genentech today announced that its Biologics License Application for ocrelizumab, marketed as Ocrevus™, has been accepted for review by the US FDA.
The monoclonal antibody, which is intended for the treatment of both relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS), has also been granted Priority Review Designation with an action date of December 28, 2016. If approved, Ocrevus will be the first treatment approved for both indications.
The application is based off data from 3 Phase III studies — OPERA I, OPERA II, and ORATORIO — which showed superior efficacy for ocrelizumab in reducing annualized relapse rates and disability progression in patients with RMS compared with interferon beta-1a disability progression in PPMS compared with placebo. Notably, ocrelizumab is administered by intravenous infusion once every 6 months compared to current first-line therapies, some of which require multiple weekly injections or daily pills.
Additionally, researchers reported at the 2016 Annual Meeting of the American Academy of Neurology that nearly 50% of patients with RMS treated with ocrelizumab reported no evidence of disease activity (NEDA) at the conclusion of the OPERA I and OPERA II trials compared to approximately 29% and 25% of patients treated with interferon beta-1a, respectively.
Overall safety of ocrelizumab was comparable to interferon beta-1a and placebo in the Phase III trials, with the most common adverse events being infusion-related reactions and infections, most of which were mild to moderate in intensity.
The drug’s Marketing Authorization Application has also been validated by the European Medicines Agency.