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 <https://creativecommons.org/licenses/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.

7 thoughts on “First drug for treatment of Progressive MS Approved by the FDA

  1. Brennon

    The FDA is not Canada so it bothers me that this is being rubbed in our faces because we can’t get the drug here.

    Reply
    1. drkarenlee Post author

      Hi Brennon,

      Thanks for your comment. We understand and recognize that many people affected by MS are awaiting a decision around this treatment. This news of the FDA approval brings hope as the first treatment approved in the world for progressive forms of MS. Having said that, an application to Health Canada has been submitted and we will provide an update as soon as we know the outcome.

      Dr. K

      Reply
    1. drkarenlee Post author

      Hi Ferne,

      Thanks for your comment.

      The MS Society offers a variety of programs and services to help people affected by multiple sclerosis as well as their families effectively manage and cope with the disease. Connect with an MS navigator by calling 1-844-859-6789 or email msnavigators@mssociety.ca.

      Dr. K

      Reply
  2. julianna ducey

    regarding drug OCRELIZUMAB please send more info, is it available in Ontario Canada. please and thank you

    The Food and Drug Administration approved on Tuesday the first drug to treat a severe form of multiple sclerosis, offering hope to patients who previously had no other options to combat a relentless disease that leads to paralysis and cognitive decline.

    The federal agency also cleared the drug to treat people with the more common, relapsing form of the disease.

    “I think that this is a very big deal,” said Dr. Stephen Hauser, the chairman of the neurology department at the University of California, San Francisco, and leader of the steering committee that oversaw the late-stage clinical trials of the drug, ocrelizumab. “The magnitude of the benefits that we’ve seen with ocrelizumab in all forms of M.S. are really quite stunning.”

    The drug, which will be sold under the brand name Ocrevus by Genentech, showed the most notable results in patients with relapsing multiple sclerosis, appearing to halt progression of the disease with few serious side effects. In patients with the more severe form, primary progressive multiple sclerosis, the drug only modestly slowed patients’ decline, but medical experts described it as an important first step.

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    Reply
    1. drkarenlee Post author

      Hi Julianna,
      Thanks for your comment. At the moment Ocrevus (ocrelizumab) is not approved in Canada. The MS Society is closely monitoring their decision and will provide an update on the blog and website as soon as we hear more. For additional information on ocrelizumab, visit our treatments in development page. Here, you will find information on ocrelizumab relating to both RRMS and progressive MS. We also have an FAQ on ocrelizumab which you can find here.
      Dr. K

      Reply

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