First drug for treatment of Progressive MS Approved by the FDA

For people living with relapse-remitting MS, 1993 was a turning point.  Before then, the only relief available to people living with MS was with the use of relapse-management therapies like steroids, which were used to decrease the severity and duration of an MS relapse by suppressing inflammation, as well as symptom management therapies. However, no options were available that could modify the underlying disease course and prevent relapses from happening in the first place. All that changed in 1993, when the U.S. Food and Drug Administration (FDA) approved the first disease-modifying therapy beta interferon 1-b (Betaseron) for the treatment of relapsing forms of MS, ushering in the era of modern MS therapy. Following Health Canada’s own regulatory approval process, Betaseron was marketed in Canada in 1995.

Credits: "approve" by hobvias sundoneighm / CC BY 2.0
Credits: “approve” by hobvias sundoneighm / CC BY 2.0 <>

Since that seminal year, 13 more disease-modifying therapies have been approved for the treatment of relapsing forms of MS. People living with relapsing forms of MS not only have access to treatments; they also have treatment options, including alternatives to injections with oral therapies, reduced dosing schedules, and alternatives in cases of unresponsiveness or intolerance to another therapy.

On the other hand, effective treatments for progressive forms of MS have been far more elusive. The search for progressive MS treatments has been affected by several notable challenges, including properly defining progression, understanding the mechanisms responsible for the accumulation of disability, and coming up with reliable biomarkers for measuring progression and response to treatment for use in clinical trials.

Just like in 1993, the tide is beginning to turn, and the treatment era for progressive forms of MS is finally upon us. On March 28, 2017, the FDA announced its approval of Ocrevus™ (ocrelizumab) for the treatment of both primary progressive and relapsing forms of MS in the US. This announcement has come on the heels of considerable anticipation that has been building since results from the ORATORIO clinical trial were first presented at the European Committee for Treatment and Research in MS (ECTRIMS) Congress in Barcelona in 2015 and then later published in the New England Journal of Medicine. The results showed that Ocrevus, developed by Genentech (Roche), eliminates harmful white blood cells called B cells that leads to a modestly but significantly reduced risk of progression of clinical disability compared to treatment with a mock drug.  Other benefits of Ocrevus include a long-term reduction in the proportion of people that progress in their  disability, decreasing the size of brain lesions, and reducing the rate of brain shrinkage.

Based on the promising results of the ORATORIO trial (not to mention the OPERA I and OPERA II trials, which showed dramatic improvements in reducing relapse rates compared to interferon beta-1a in participants with relapsing forms of MS), the FDA fast-tracked the approvals process of Ocrevus to ensure it would be completed by the first quarter of 2017. While this can seem like an eternity for people who have been waiting years or decades for a breakthrough, it is encouraging to see that clinical trials for progressive forms of MS have begun to make a striking impact on the treatment landscape and are becoming a top priority for regulatory bodies.

What does this news mean for Canadians living with primary progressive MS? We do know that Genentech has submitted a drug marketing application for Ocrevus to Health Canada. FDA approval only covers marketing of a drug in the United States, and Health Canada needs to conduct its own review of data related to a drug before deciding to market a new drug in Canada. We’ll be keeping a close eye on the status of Ocrevus’ application to Health Canada – in the meantime, take a look at our Frequently Asked Questions which we will be keeping up-to-date with the latest news.

Categories Research

National vice-president, research, past MS researcher, and PhD in Cellular and Molecular Medicine from University of Ottawa. Leads the MS Society's research program to find the cure for MS and improve the quality of life for people affected by the disease.

Leave a Reply

Your email address will not be published.