Tuesday, March 28, 2017

Ocrevus Approved by FDA for Relapsing MS and Progressive MS

The new MS drug Ocrevus (generic name ocrelizumab) was approved today for use in patients with both relapsing multiple sclerosis AND progressive multiple sclerosis (click here). Ocrevus is the first drug to receive FDA approval for the treatment of progressive multiple sclerosis, thus representing a milestone in the history of MS treatments.

While this is exciting news for people with progressive MS, it's important that patients keep their expectations reasonable and in line with what was shown in the Ocrevus clinical trials. Ocrevus could very well prove to be the most effective relapsing MS drug available when it hits the market (which should be in about 2 weeks); it will be the only FDA approved MS drug for progressive MS when it hits the shelves. Based on the Ocrevus progressive MS trial results, some patients may expect to see a slowing of their disease progression by about 25%. There is some reason to believe that the drug will work best on patients with enhancing lesions on their MRIs. While this is not nearly the kind of momentous intervention all patients with progressive MS crave, it is a start, and one would expect to see an increase in research for this type of MS as other pharmaceutical companies race to get competing drugs on the market.

I've reposted a commentary on Ocrevus I wrote back in January, after interviewing one of the lead researchers on the drug, Dr. Peter Chin. I would encourage all readers with an interest in Ocrevus to read my commentary (click here) and the interview with Dr. Chin (click here). Both include important info for patients considering taking this drug.

As long-time readers of Wheelchair Kamikaze are undoubtedly aware, I've often been skeptical when it comes to MS drugs. However, I owe it to myself and my readers to go where the science takes me, and there is an ever increasing body of evidence that the newer generation of immunosuppressive MS drugs do positively impact the course of the disease, sometimes dramatically. Many of them do carry with them a list of serious and sometimes fatal potential side effects, and as always a frank discussion with your neurologist is mandatory when considering the risk/reward ratio before beginning any drug treatment. Let's hope that with time Ocrevus shows itself to be even more effective than was demonstrated in its clinical trials, and that its safety profile proves robust.

Wishing all WK readers and those who love them the realization of their fondest dreams…


7 comments:

  1. Dear Marc ... and all your followers!


    Please read this - I quote:


    " In a market already bulging with expensive drugs for that form of MS, Roche set an annual price of $65,000 for the twice-a-year infusions. A study in the journal Neurology in 2015 that looked at nine of about a dozen MS drugs that modify the course of relapse-remitting disease found that none was priced under $50,000 a year, not including drug company rebates. Prices have generally risen since.

    Roche acknowledged concerns about drug pricing in disclosing the amount, saying that the National Multiple Sclerosis Society recently noted that MS medicines cost almost four times what they did 12 years ago. Roche said its list price is 25 percent less than Rebif, the drug ocrelizumab outperformed in two of of the major studies leading to approval. Rebif lists for $86,000 a year, the company said, adding that the “industry needs to start reversing” the pricing trends. "

    Source:
    https://www.statnews.com/2017/03/28/multiple-sclerosis-ms-drug-ocrelizumab/


    My comment:
    I am on Rituximab myself, which is essentially the same drug as ocrelizumab - Yes it is. But of course Roche will do anything in their power to differ it from low priced Rituximab - rest assured that!


    Now it makes me really, really furious, that Big Pharma, out of respect for MS-patients can not be really honest even at this moment.


    Roche state in statements, that the drug will be priced lower than other drugs, because ms-drug prices have to come down.


    THE ONLY REASON they say this, is that they fear competition from low priced Rituximab. You will never find these kind of reasoning and arguing with Roche´s other new drugs .... unless their is a similar competition issue as with Ocrelizumab versus Rituximab ...


    All the doctors out there now this marketing trick, but when Roche state this, they addresses themselves to the patients. Such hypocrites.


    Not even in this moment, they can be straight and honest towards the ms-patients.


    As for me, I stay on Rituximab.


    So no tears for Big Pharma Roche

    Warm regards

    Elisabeth

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    Replies
    1. Not exactly the same - see this article:
      https://www.quora.com/How-does-ocrelizumab-differ-from-rituximab

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    2. Yes, there is actually a pretty significant difference in mechanism of action between the two drugs. Rituxan kills B cells pretty much on its own, but Ocrevus calls on the help of other immune system cells. This means that Ocrevus has a greater impact on the overall immune system then Rituxan, which, paradoxically, could make it both more effective and less safe.

      Patients must have a frank discussion with their doctors about any drug. Ocrevus is getting a huge promotional push by the pharmaceutical company that makes it, with MS neuros targeted intensely. Do your best to cut through the BS. Not saying this isn't a good drug, but many doctors will be highly motivated to prescribe it above all else…

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  2. Approved for RRMS, PPMS. What about SPMS?

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  3. The greatest human endeavour - science. We should all be greatful we are living in the age of critical thinking and secularism. Thanks WK for your, as always, objective wrap up of this important news. Good luck to everyone contemplating this new medicine.

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  4. Marc,
    Not to get too personal, but will you be trying Ocrevus? I understand if you don't wish to answer. And, understanding how each person's MS progresses at a different mysterious rate, I am not impressed with the stats on this drug...but what do I know?????

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