Ocrevus Receives FDA Greenlight for Relapsing, Primary Progressive Forms of Multiple Sclerosis

Tuesday, March 28, 2017 | Clinical Trials , FDA Approval/Clearance , Neuromuscular & Immune Disorders , Phase 3/4 Trials , Research and Publications , Genentech , Roche


The FDA has approved Ocrevus (ocrelizumab, Roche/Genentech) for the treatment of both relapsing and primary progressive forms of multiple sclerosis. Ocrelizumab is a humanized antibody that targets CD20 marker on B lymphocytes. It is the first drug approved in the US for the treatment of primary progressive MS. The approval was based on phase 3 results in both relapsing and primary progressive MS.

In two identical studies evaluating ocrelizumab in relapsing MS known as the OPERA trials, the annualized relapse rate was lower in patients treated with 600 mg ocrelizumab every 24 weeks for 96 weeks than with interferon beta-1a. Moreover, the percentage of patients with disability progression was significantly lower with ocrelizumab than with interferon beta-1a at both 12 and 24 weeks. Regarding adverse events, infusion-related reactions occurred in 34.3 percent of the patients treated with ocrelizumab, the researchers observed. Serious infections, however, were lower in the ocrelizumab group.

According to Patricia K. Coyle, MD, Professor of Neurology and Vice Chair of Clinical Affairs at Stony Brook University, ocrelizumab is a high efficacy agent that’s not only extremely well tolerated but also comes with a favorable dosing schedule, making it a unique addition to the treatment armamentarium. “The patient is going to an infusion center for a couple of hours, two days out of the year, which is both convenient and ensures adherence.”

In the primary progressive MS trial (ORATORIO), the percentage of patients confirmed disability progression at 12 weeks was 32.9 percent in patients treated with ocrelizumab versus 39.3 percent with placebo. That percentage dropped to 29.6 percent with ocrelizumab at 24 weeks versus 35.7 percent with placebo. At the end of the study, performance on the timed 25-foot walk worsened by 38.9 percent in patients treated with ocrelizumab, as compared to 55.1 percent with placebo.

In primary progressive MS, Dr. Coyle observes that the benefits appear to be predominantly upfront, demonstrating an anti-inflammatory impact as opposed to documenting a true effect on neurodegeneration. Nevertheless, she notes that the mere presence of a therapy for this condition is a much-needed boost. “We have not yet had a disease modifying therapy for a pure progressive form of MS, which makes the approval of any agent in a huge psychological benefit for patients and physicians alike,” Dr. Coyle notes.

Ocrevus will be available within two weeks. Genentech will be offering comprehensive services for people prescribed Ocrevus to help minimize barriers to access and reimbursement.

           

See the upcoming April edition of Practical Neurology for more reflections from Dr. Coyle on the approval of ocrelizumab and how it may impact the evolving MS treatment spectrum.

 

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