FDA Approves Ocrelizumab for Two Types of Multiple Sclerosis

The US Food and Drug Administration (FDA) today approved ocrelizumab (Ocrevus/Genentech) as the first and only medication to treat patients with relapsing and primary progressive forms of multiple sclerosis (MS).

The approval followed two RMS phase 3 studies (OPERA I and OPERA II) that administered 600mg Ocrevus by intravenous infusion every 6 months or 44mcg of interferon beta-1a (Rebif) by subcutaneous injection 3 times per week to 1,656 people with relapsing forms of MS.

According to the results, Ocrevus demonstrated “superior efficacy” on the 3 major markers of disease activity — it reduced annual relapses by nearly 50%, slowing the worsening of the disability.

Also, researchers found that compared to Rebif, patients in the ocrelizumab group experienced a significant reduction in MRI lesions over the 2-year controlled treatment period. Compared with people in the high-dose interferon beta-1a group in the RMS studies, a similar proportion of people in the ocrelizumab group experienced serious adverse events and serious infections.

Furthermore, in a separate PPMS phase 3 study, ORATORIO, experts noted that ocrelizumab was the first and only treatment to significantly slow disability progression and reduce signs of disease activity in the brain compared with placebo with a median follow-up of 3 years. The team reported that a similar proportion of people in the OCREVUS group experienced adverse events and serious adverse events compared with people in the placebo group in the PPMS study.

According to the results, the most commonly reported adverse events in all phase 3 studies were infusion reactions and upper respiratory tract infections, which were mostly mild-to-moderate in severity.

Sandra Horning, MD, chief medical officer and head of Global Product Development, FDA, said in a news release, “We believe OCREVUS, given every six months, has the potential to change the disease course for people with MS, and we are committed to helping those who can benefit gain access to our medicine.”

Officials reported that Ocrevus would be available in the United States within the next two weeks.