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.

13 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 Helene,

          Thanks for your question. Individuals are encouraged to discuss treatment options with their healthcare team. The MS Society of Canada does not provide a list of clinics in the U.S. who offer ocrelizumab infusions. There are a number of important considerations that one should be mindful of when considering traveling abroad for medical treatments. Click here to read through these considerations in more detail.
          Thanks,

          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
      1. Teresa

        I have progressive MS so no meds to assist me, I was able to get 300mg Biotin compound to try and have some little improvement but drug plan will not cover so any idea?

        Reply
        1. drkarenlee Post author

          Hi Teresa,

          Thanks for the question. Biotin is still in the experimental phase as researchers are looking to see if it can improve progressive MS. The treatment is called MD1003. The compound was tested in two phase III clinical trials testing the safety and benefits of MD1003. Both these trials show positive outcomes in disease progression. A large phase III trial is currently underway and will include Canadian sites. It is important to note that the dosage being tested in the clinical trials (300mg/day) is 10,000 times higher than the Health Canada recommended daily intake of 30 µg/day. Also, we currently do not have long-term safety of taking the ultra-high doses of biotin for a prolonged period of time. Check out the link here for more information on MD1003. We continuously update our website for treatments that are in development like MD1003 and also treatments that are approved by Health Canada.

          Thanks,

          Dr. K

          Reply
  3. Deb Dewar

    I have R/R MS and agree with David Oakes!…when will there be a cure!….can the Polio Vacination not be seen as a link to MS?
    Why is it taking so long to find a cure for this illness?

    Deb Dewa

    Reply
    1. drkarenlee Post author

      Hi Deb,
      Thanks for your question. MS is complicated and requires experts from multi-disciplinary fields such as neurology, immunology, and virology. We are still working to figure out what triggers MS, how it works, what progresses it. To figure out this important information, the MS Society has committed funding to the best researchers in MS in Canada. In addition to the research we fund on an annual basis, we launched a new initiative called MS Society of Canada-Brain Canada- Biogen MS Progression Cohort. This initiative will bring together some of the brightest minds in MS research in Canada looking at how and why progression in MS occurs in the hope to find treatments that will halt and reverse MS.
      In reference to your question on MS and Polio vaccine, there are nine studies performed on the polio vaccination and MS and from these studies there was no risk of developing MS and no risk of relapse following the polio vaccine. The most up to date information was recently (June 2017) published here.
      Dr. K

      Reply

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