FDA approves Genentech’s Ocrevus for multiple sclerosis treatment

In a landmark decision, the US Food and Drug Administration (FDA) has granted approval to Genentech, a subsidiary of the Roche Group, for its multiple sclerosis (MS) drug, Ocrevus (ocrelizumab). This approval marks Ocrevus as the first and only therapy available for both relapsing and primary progressive forms of multiple sclerosis, addressing a significant unmet need within the MS community.

Breakthrough Therapy for MS

Ocrevus, administered through intravenous infusion, is now the first FDA-approved drug for treating Primary Progressive MS (PPMS), a form of MS that had no approved therapies until now. Additionally, it offers a new treatment option for Relapsing MS (RMS), providing hope for patients who continue to experience disease activity despite existing therapies.

Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, highlighted the drug’s impact: “Multiple sclerosis can have a profound impact on a person’s life. This therapy not only provides another treatment option for those with relapsing MS, but for the first time provides an approved therapy for those with primary progressive MS.”

Clinical Trial Success

The efficacy of Ocrevus was demonstrated in pivotal Phase III clinical trials, namely OPERA I and OPERA II for RMS, and ORATORIO for PPMS. In these studies, Ocrevus significantly reduced disease activity and disability progression compared to high-dose interferon beta-1a, Rebif. The trials showed that Ocrevus halved the relapse rates per year, decelerated the worsening of disability, and significantly reduced MRI lesions during a two-year treatment period.

Sandra Horning, M.D., Genentech’s Chief Medical Officer and Head of Global Product Development, expressed optimism about the therapy’s potential: “The FDA’s approval of Ocrevus is the beginning of a new era for the MS community and represents a significant scientific advance with this first-in-class B cell targeted therapy.”

Commitment to Accessibility

Genentech has announced that Ocrevus will be available in the US within two weeks, emphasizing the company’s commitment to ensuring that those who can benefit from this novel therapy will have access to it.

The approval of Ocrevus by the FDA is a critical advancement in the treatment of multiple sclerosis, potentially changing the course of the disease for many patients. With its innovative approach targeting B cells, Ocrevus paves the way for future therapies in the landscape of autoimmune and neurodegenerative diseases.