Still Waiting on Ocrevus

Still Waiting on Ocrevus
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MS_Wire_Ed_Tobias
Several months ago I wrote a blog on my personal website about Ocrevus (ocrelizumab), the first drug that’s designed specifically to treat primary progressive, as well as remitting, multiple sclerosis. The clinical trials for Ocrevus posted excellent results. The buzz in the medical community was good,  and it was hoped that Ocrevus would receive final approval for use in the U.S. by the end of this year.

Wednesday night the CBS Evening News broadcast a very positive report about the drug.

 

Alas, there will be no final approval by year’s end. The U.S. Food and Drug Administration extended its review of Ocrevus the day before that CBS report was broadcast. Genentech, the company that makes the drug, says the FDA has now set March 28 for its review of the Ocrevus license application. According to Genentech, the delay came because the FDA asked for additional information about the manufacturing process for the drug. The extension, Genentech wrote in a news release, is not related to the efficacy or safety of Ocrevus.

“We strongly believe in the potential of Ocrevus as a new therapeutic option for both people with relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS),” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “We are working closely with the FDA during their review and are committed to bringing this innovative medicine to the over 400,000 people with MS in the U.S. living with this disabling disease, as quickly as possible.”

Well, let’s hope so. While I was researching Lemtrada infusions, (and I’m happy to say that I continue to do well as I approach two weeks after my Round 1 infusions), I ran into a lot of MS patients who would like to be receiving that drug. For them March 28, and hopefully final FDA approval of Ocrevus, can’t come soon enough.

This is my final column for 2016. I hope your holiday, whichever you celebrate, is joyous and that the new year brings better health to us all.

Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today, or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to multiple sclerosis.

Ed Tobias is a retired broadcast journalist. Most of his 40+ year career was spent as a manager with the Associated Press in Washington, DC. Tobias was diagnosed with Multiple Sclerosis in 1980 but he continued to work, full-time, meeting interesting people and traveling to interesting places, until retiring at the end of 2012.
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Ed Tobias is a retired broadcast journalist. Most of his 40+ year career was spent as a manager with the Associated Press in Washington, DC. Tobias was diagnosed with Multiple Sclerosis in 1980 but he continued to work, full-time, meeting interesting people and traveling to interesting places, until retiring at the end of 2012.

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9 comments

    • Ed Tobias says:

      Dianne,

      The clinical trials of ocrelizumab, which Genetech plans to market under the brand name Ocrevus, only involved RRMS and PPMS patients. So Genetech’s application to sell the drug only involves those two aspects of the disease. The trials, and therefore the application, did not include SPMS. I suspect, however, that some neurologist may prescribe Ocrevus for SPMS patients even though it’s not approved for that use.

    • Jamie Masone Sedlock says:

      I took Tysabi for my relapsing remitting multiple sclerosis . Within a years time I came down with PML it’s a rare often fatal infection in my brain .
      I’m wondering if Stem Cell Therapy would work for me ?

  1. Claudius says:

    Why Ocrelizumab has not been tested also for SPMS?
    In my opinion it should be applied succesfully also for this form of MS. There are no treatments for this form of the diesease.

  2. Lynette I Carroll says:

    Try looking in to rituxumab. 1st generation immunotherapy drug used off label to treat spms,ppms and rrms. Been on it for 2 yrs and counting. I have spms and just finished my 2 year mark.

  3. Well once again the FDA proves that they could care less about our health. This is obviously a monetary thing. Ocrevus is going to put a billion dollar a year hit into Biogen according to their news bulletin. Gee I wonder what the hold up is. This is absolutely ridiculous. The FDA should be fined for every day beyond the first quarter of 2016 when Ocrevus was supposed to come out. It’s been proven safe and a working drug in trials for five years. What more do they want. Once again a crooked government entity that can do whatever they want with no repercussions, while we suffer as the little people. Something needs to be done about this.

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