1st Potential Therapy for Primary Progressive MS, Ocrelizumab, Under Priority Review by FDA

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MS and the need for a cure

The U.S. Food and Drug Administration (FDA) is giving priority review to a request to approve Ocrevus (ocrelizumab) as a treatment for both forms of multiple sclerosis, the drug’s developer, Genentech, announced. If the company’s Biologics License Application (BLA) is approved, Ocrevus will become the first drug able to treat patients with either relapsing or primary progressive MS.

By designating the review a priority, the FDA will make its decision within six months rather than the standard 10, and release that decision on Dec. 28. Approval means the drug will be available for patients in the U.S.

A similar regulatory process is underway in Europe, with the European Medicines Agency (EMA) having approved the company’s Marketing Authorization Application (MAA) for Ocrevus and taken it under review for use throughout the European Union.

“OCREVUS is the first investigational medicine to significantly reduce disability progression in people with relapsing and primary progressive forms of MS,” Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, said in a press release. “We are pleased by the FDA’s decision to classify their review of the BLA as priority, because we believe OCREVUS has the potential to help people living with either of these two forms of MS.”

Although a number of treatments already exist for relapsing MS, none are able to treat the disease’s primary progressive form. An estimated 95 percent of all MS patients are diagnosed with either one of these two types.

Genentech’s applications for U.S. and EU approval of Ocrevus are based on three randomized, double-blind, and large Phase 3 clinical trials. OPERA I and OPERA II were identical studies that demonstrated Ocrevus’ superior efficacy in patients with relapsing MS (RMS) compared to Rebif therapy (interferon beta-1a). Ocrevus was shown to decrease annual relapse rate by almost 50%, and to reduce the total number of new or enlarging brain lesions by 77% and 83%, respectively, in the two studies. Furthermore, half of the patients on ocrelizumab therapy had no evidence of relapses, disability progression and brain lesion activity, compared to 25% to 30% of the patients taking Rebif.

Data from the ORATORIO trial, in primary progressive MS patients (PPMS), demonstrated significant reductions in disability progression and reduced brain atrophy compared to placebo. In all three trials, Ocrevus therapy was set at 600 mg given by intravenous infusion every six months.

Ocrevus (ocrelizumab) is a humanized monoclonal antibody designed to selectively target CD20-positive B cells, a type of immune cell thought to contribute to the myelin (a nerve cell insulator) and nerve cell (axonal) damage that results in MS. The therapy is designed to bind to CD20 cell surface proteins expressed on certain B-cells, although not to stem cells or plasma cells, so as to preserve key immune system functions.

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  1. Kym says:

    My Dr. Told me the same side effects are very probably with this drug. Like PML. Does anyone know what the side effects of this drug are?

  2. Sadie says:

    How does this compare to the effectiveness of Tysabri? I only see comparison to Rebif which is not effective (for me anyway). Do you think people will switch to this as a more powerful drug alternative? I have been on Tysabri for 8 years the other DMD’s were no help. Diagnosed 22 years ago. I also wonder if there was a study done on how people will go about switching if there would have to be a washout period or if it’s safe to switch from Tysabri to this? I would love to be able to try something new to slow progression at this point.

  3. Robin Lee says:

    I’ve been waiting for almost a year for this to get approved. I. have been on several medications with no help with my MS symptoms. My last one was Rituxan infusions which I had a reaction to. Please get this approved quickly so I can try this. Let me know as soon as you know anything.

  4. Collette says:

    Is there any idea what the cost might be for this drug if approved? I have just recently been diagnosed with Primary Progressive. I am 69 and have been struggling with symptoms over several years prior to being diagnosed.

  5. Jeffrey Lagomacini says:

    Robin Lee, this Med stems from the same origin of Rituxan.
    They’re are basically the same thing but Rituxan is 50% human/50% animal while this one is100% “humanized”.
    I am hopeful that this one would help you more & with no reactions!

    • Janette Coombs says:

      Janette Coombs Diagnosed in 2002 and now have PPMS.Have never been offered a disease modifying treatment and would greet this “outstanding” chance to try!

  6. RS says:

    I’m also in Rituxan. I have no side affects. I was just recently diagnosed October 29, 2015. On November 10, 2015 I fell down in my bathroom, completely paralyzed from my breast down. My arms were numb and tingling but I was able to move them. I had a plasma pheresis, IVIG, and Rituxan done. I am happy to say I am now at home with my Family after 2 months and 2 days of living in hospitals. Rituxan has been good to me so far. I was diagnosed with G35 MS.

  7. J. W. T. says:

    The article states that 95% of people with MS are diagnosed with either RRMS or primary progressive MS. This is not what I’ve always understood. What happened to the secondary progressive MS category? And will ocrelizumab be effective for people with secondary progressive MS?

  8. Michelle A Rucci says:

    I have the same questions as J.W.T. About the secondary type of ms
    I’ve had Drs say to me primary secondary they are all the same! I wd love more info on this drug! Very hopeful, Michelle at the shore

    • Donna Johnson says:

      I also have PP MS and high blood pressure currently taking medication for it. When will this be available? Thank you for thank you for your response

  9. Phil Longford says:

    Hopefully the side effects are limited, but how do those who were on the trials, and are claiming no side effects, know that they were actually on the drug, not the placebo? Sounds encouraging, though, as nothing else out there, for PPMS!

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