Ocrevus: Counting Down to Expected FDA Approval

Ocrevus: Counting Down to Expected FDA Approval

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There is now less than a month until the U.S. Food and Drug Administration (FDA) is expected to approve Ocrevus, generic name ocrelizumab, for use as a therapy for multiple sclerosis.

Clinical trials have shown Genentech’s drug to be a promising therapy for relapsing MS and, significantly, the primary progressive form of the disease for which there is no approved treatment.

The FDA is due to make its decision known March 28, which is quite poetic really, in that it is MS Awareness Month.

So, if everything works out, it looks as if Ocrevus, although not a cure, has all the makings of a wonder drug for MS, at least for most people who have the disease. That is because the vast majority of people with MS have the relapsing form, some 85% worldwide are diagnosed with this type..

However, if, like me, you have secondary progressive MS, then it seems Ocrevus will not be available. No claims have been made of Ocrevus having any effectiveness for our form of MS.

All drugs have side effects and this new one is no exception, but it seems that in all studies the most frequent side effects were mild-to-moderate reactions and infections related to the treatment’s injection.

But that is not enough information for me, and it should not be for you. I decided to dig a little deeper.

The UK’s MS Society says that not one of the Phase 3 trials reported any unexpected adverse side effects and in the Phase 2 relapsing remitting trial, serious side effects were rare and were comparable for all groups.

Wait a minute. Serious side effects?

The UK’s MS Trust also says they are rare and adds that opportunistic infections have not been reported in ocrelizumab MS trials.

Furthermore, in his article “Genentech’s Ocrevus: Pioneering The Progressive MS Therapy Landscape”, on Pharmaceutical Online, John Crowley, PhD, of Decision Resources Group, said: Ocrevus’ safety profile in MS program is very strong, but some question marks remain.”

It looks to me that, overall, the Ocrevus story is a very positive one.

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[You are invited to visit my personal MS, Health & Disability website at 50shadesofsun.com].

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.

22 comments

  1. Rita says:

    Looks to be very effective, yes, but be careful of using the phrase ‘wonder drug’ (unless you set your threshold for wonder quite low)
    Also, 85% of people with MS don’t have relapsing remitting MS. 85% are diagnosed with that form, but at any time about 40-45% will be living with RRMS and a similar proportion will have SPMS.

  2. Ian Franks says:

    Hi Rita, thanks for your comment. Some 85 percent are diagnosed with relapsing MS but, as you say, a proportion of these, like me, go on to develop SPMS.

  3. David says:

    I fear that the proposed cut backs by the president will affect research which means we all lose. I recommend we all call our US Representatives and Senators. We need to forget the party politics and become U.S citizens again.

  4. Nikki Ely says:

    Hi Ian-thank you for the information and your nice excerpt on OCrevus. My neurologist has put me on the waiting list for this new medicine so I hope it is approved by the FDA, not only for me but for others who suffer too. I have RRMS with frequent relapses and I am currently on Tysabri. Hope you are doing well.
    Thanks, Nikki Ely

    • Danni says:

      I too am waiting for this new drug. My neurologist says we should be able to be prescribed the drug by June, it all goes well on the 28th. I am also on Tysabri, RMS. Looking forward to good things ahead!

  5. It’s about time.the FDA has been dragging their feet on ocrevus for a year now.I guess no more bribes can hold it back hopefully.My condition has worsened greatly while waiting on this sadistic,could care less about us federal organization. I blame my condition soley on the FDA.This med was supposed to be available in the 1st quarter of 2016. Thank you FDA. One of The most worthless government organizations on the planet. Unless you’re the pharmaceutical companies.

  6. Mohammed says:

    Hi I have PPMS with mild secondary relapse I’m waiting for Acrevus Any news about the date it will be available

  7. Margaret Murray says:

    I have PPMS and since my diagnosis in 07 I’ve gone from worke full time to having to use a wheel chair. It would be great if there was medication that help people with PPMS then maybe I would have been able to keep on working. I live in hope .

  8. Dale Rawson says:

    On the paperwork from the first MRI I had PPMS but the doc said I was having relapses and I try to tell them nothing has ever gone away like the ringing in the ears an electric white legs toes to knees and frustrating numb fingers I asked my dog to try this. Not my MS group I call it the “O” drug cuz I can’t pronounce the name but here’s hoping.

  9. Terry says:

    I guess the more drugs for MS, the more there will be one that helps somebody. Since 1988 when I was diagnosed and the only response was Prednisone, research has come far. But not far enough. I’ve tried every injection, but continued to get new lesions in brain and spine. Have been on Tecfidera for 3 yrs now, and no new lesions.

    In the interim, the first 11 yrs didn’t phase me as exacerberations would come and go with no lingering damage. Then BOOM! I can’t pinpoint that I had an exacerbation here and there that caused damage. Just over time the bad neuropathy hit, the fatigue never went away, the walking became difficult and the pain frustrating. So it went from RRMS to SPMS gradually. But damn..I don’t have any new lesions so that’s good news!

    Every drug I take has side effects. The Prednisone trashed my bones. I have severe Osteoporisis to boot and am a prime candidate for stress fractures. My Rheumatologist tells me to be careful when walking because I could break a lot of bones. I just laugh and tell him to talk to my Neuro on the third floor. Bets are pouring in.

    Blah, blah, blah. Sorry. In closing, every one should be wary of new drugs. At the same time, they will all have side effects. But one may work better for you than another.

    Good luck to us all!

  10. Sara says:

    I’m in one of the studies for Ocrelizumab and I’ve had one infusion so far. I’m one of the most cynical people you’ll find, especially when it comes to new medications, but I’m really, REALLY impressed with it so far. I feel better than I have in years. My fatigue is better (not gone, but definitely not as bad), I sleep better, my MS hug has decided to give me a break, and the terrible spasticity I’ve dealt with for the last few years is practically non-existent. I hope and pray that they make this available soon for everyone.

    • Tim Bossie says:

      That’s fantastic Sara! Thank you for sharing your experience with this community. We hope that there are many others who are able to benefit from this new medication as well. 🙂

    • Vicki CFS says:

      I was diagnosed with PPMS in May 2012, when I was 50 years old. Having no true medication for PPMS patients has been discouraging and frustrating. I am THRILLED to hear this has finally been approved. I was excited to hear that your (Sara) spasticity is almost gone! That is my #1 problem and knowing that Ocrelizumab has helped that is an answer to my prayers! My next dr appointment is in May and I plan on getting a prescription for O before I leave the office! 🙂 Prayers for us all…

  11. Gary W. says:

    Sara you did not say what kind of MS you have, I am one of the 10% with PPMS and was diagnosed ten years ago I am currently in a clinical study at the NIH the drug is idebenone unfortunately it does’ not seem to do anything for me, so hopefully ocrelizumab will get approval and it will help me and other PPMSers.The neurologist at the NIH thinks it is a very good drug and said to get on it ASAP even though it will force me out of there study.

  12. Shirley Nobbs says:

    Is there any indication when it will be released to the public and how much it will cost?
    I live in Canada so am wondering when we may be able to get it?

    • Rick says:

      I was diagnosed with RMS 16 years ago. My biggest problem is with my walking, my endurance, and my balance. I am very excited about the possibility of living a more normal life.

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