Results 1 to 9 of 9

Thread: FDA expedites review of ocrelizumab for PPMS

  1. #1
    Distinguished Community Member agate's Avatar
    Join Date
    Oct 2006
    Location
    USA
    Posts
    6,582
    Blog Entries
    11

    Default FDA expedites review of ocrelizumab for PPMS

    A notice from the MSAA, February 17, 2016:

    FDA Expedites Review of Ocrelizumab for the Treatment of PPMS



    The United States Food and Drug Administration (FDA) has granted “Breakthrough Therapy Designation” for ocrelizumab, an experimental medication presently under investigation for the treatment of primary-progressive multiple sclerosis (PPMS). At this time, no treatments are available for this less-common form of MS.

    With this designation, the FDA affirms: (1) the medication would be used to treat a serious condition; (2) preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies; and (3) the review process would be expedited to within 60 days.

    In contrast to relapsing-remitting MS (RRMS) – the most-common type of multiple sclerosis affecting 80 to 85 percent of people diagnosed with MS – about 10 percent of the MS population is diagnosed with PPMS.

    Individuals with PPMS experience a steady worsening of symptoms from the start, without the periodic relapses and remissions experienced by people with RRMS. While 13 disease-modifying therapies are currently approved for relapsing forms of MS, no long-term treatments have been approved for PPMS.

    Genentech, a member of the Roche group, is the company developing ocrelizumab. They have submitted the brand name Ocrevus™ to the FDA for this investigational medication, noting that this is the first drug for MS that has been designated as breakthrough therapy by the FDA.

    Ocrelizumab is an investigational, humanized monoclonal antibody designed to selectively target CD20-positive B cells. Genentech explains that these are a specific type of immune cell thought to be a key contributor to myelin and axonal damage, which can result in disability in people with MS.

    According to Genentech, the breakthrough designation is based on positive results from the pivotal Phase III ORATORIO study. Top-line results from this study were presented at the 31st congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in October 2015.

    These results stated that the trial met its primary endpoint, showing that treatment with ocrelizumab in PPMS significantly reduced the progression of clinical disability sustained for at least 12 weeks compared with placebo. Walking speed, as measured by the timed 25-foot walk, was improved by 29 percent. The incidence of adverse events associated with ocrelizumab was similar to placebo; the most common adverse events were mild-to-moderate infusion-related reactions. MRI hyper-intense T2 lesions were actually reduced by ocrelizumab, and brain-volume loss as viewed on MRI was reduced by 17.5 percent. ...

    Readers should note that this breakthrough designation with the expedited review period has only been granted by the FDA for the one indication, which is for the long-term treatment of PPMS. Genentech also plans to seek approval of the medication for the long-term treatment of relapsing forms of MS in the near future. They plan to submit data from additional Phase III studies to the FDA in the first half of 2016.

    MSAA Chief Medical Officer Dr. Jack Burks states, "This is very exciting news. Ocrelizumab is the first disease-modifying therapy with positive disability results in PPMS. In addition, the safety data were similar to placebo controls. However, FDA approval will require intense scrutiny of these data. Effectiveness combined with safety is the magic formula, and we’ll see if the FDA agrees that ocrelizumab meets both requirements for approval in PPMS."

    For more information or to speak with a trained Client Services Specialist, please call MSAA's Helpline at (800) 532-7667, extension 154. Questions to MSAA's Client Services department may also be emailed to MSquestions@mymsaa.org.

    ________

    Written by Susan Wells Courtney, MSAA Senior Writer
    Reviewed by Jack Burks, MD, MSAA Chief Medical Officer
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.


  2. #2
    Distinguished Community Member
    Join Date
    Oct 2006
    Location
    North Carolina
    Posts
    3,217

    Default

    Agate, thanks for posting this. If it really works, what a break through for PPMS people. Also, possibly for other groups down the road. I see it is given by infusion, so unless someone comes to a person's home that person will have to get to an infusion center or Doctor's office on their own. Still sounds like good news to me.
    Virginia


  3. #3
    Distinguished Community Member agate's Avatar
    Join Date
    Oct 2006
    Location
    USA
    Posts
    6,582
    Blog Entries
    11

    Default

    Looks as if it will be known as Ocrevus. I'm not sure how to pronounce it but then MS drugs tend to be hard to pronounce.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.


  4. #4
    Distinguished Community Member SalpalSally's Avatar
    Join Date
    Oct 2006
    Location
    SWOhio
    Posts
    3,569

    Default

    Sounds like a mother scary, watch for JC virus,mononuc med?
    Love, Sally


    "The best way out is always through". Robert Frost







  5. The following 5 users say "thanks"


  6. #5
    Distinguished Community Member agate's Avatar
    Join Date
    Oct 2006
    Location
    USA
    Posts
    6,582
    Blog Entries
    11

    Default

    Isn't there a risk of PML with any monoclonal antibody?
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

  7. The following 8 users say "thanks"


  8. #6
    Distinguished Community Member Lazarus's Avatar
    Join Date
    Oct 2006
    Location
    western MA
    Posts
    968

    Default

    This is the drug my. Neuro talked with me about ...maybe a year ago.
    I think it is a newer version of RItuximab...rituxan.
    I remember my thought that it will be a more expensive version of rituxan which is not all that different.

    Anyway, rituxan has a good record for being tolerable with few side effects.
    Linda~~~~

    Be the kind of woman that when your feet hit the floor each morning the devil says:"Oh Crap, She's up!"

  9. The following 6 users say "thanks"


  10. #7
    Distinguished Community Member agate's Avatar
    Join Date
    Oct 2006
    Location
    USA
    Posts
    6,582
    Blog Entries
    11

    Default

    There was this thread a while back:

    http://www.braintalkcommunities.org/...n-MS-treatment
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

  11. The following 6 users say "thanks"


  12. #8
    Distinguished Community Member SalpalSally's Avatar
    Join Date
    Oct 2006
    Location
    SWOhio
    Posts
    3,569

    Default

    Have any of these meds actually stopped the progression of our MS?
    I believe there are some Tysabri users who think so?

    I'd love to hear peeps stories of their Meds!
    Last edited by SalpalSally; 02-19-2016 at 07:06 AM.
    Love, Sally


    "The best way out is always through". Robert Frost







  13. The following 6 users say "thanks"


  14. #9
    Distinguished Community Member agate's Avatar
    Join Date
    Oct 2006
    Location
    USA
    Posts
    6,582
    Blog Entries
    11

    Default

    Quote Originally Posted by SalpalSally View Post
    This quote is hidden because you are ignoring this member. Show Quote
    Have any of these meds actually stopped the progression of our MS?
    I believe there are some Tysabri users who think so?

    I'd love to hear peeps stories of their Meds!
    That's the gray area, isn't it? Or one of them? Since most people on the DMDs have RRMS, who knows if they'd have had a lot of remission even if they hadn't taken a DMD?

    It's possible that many would have done just as well without any DMD. Or maybe they'd have done even better without treatment.

    The experts look at the statistics--at how many people with RRMS had relapses over how long a time without being on a DMD and how many people with RRMS had relapses over the same period of time while being on a DMD, and they find that the DMD group had significantly fewer relapses than the other group. Therefore (they tell us) the DMDs are helping.

    Except that it's hard to know which individual people were helped because MS can go easy on you or it can act up in a big way.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

  15. The following 7 users say "thanks"


Similar Threads

  1. Replies: 4
    Last Post: 10-11-2015, 06:30 AM
  2. Replies: 11
    Last Post: 05-01-2015, 05:32 AM
  3. Mitoxantrone doesn't work for PPMS
    By SuzE-Q in forum Multiple Sclerosis
    Replies: 4
    Last Post: 12-11-2014, 10:22 AM
  4. Triennial Review of Jon's Services
    By Earth Mother 2 Angels in forum Child Neurology
    Replies: 10
    Last Post: 07-29-2014, 07:58 PM
  5. New Review Article
    By xtcds1 in forum Cerebrospinal Fluid (CSF) Leak
    Replies: 2
    Last Post: 11-01-2011, 03:56 PM

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •  


BTC Inc's Disclaimer and Privacy Policy

The material on this site is for information & support purposes only, and is not a substitute for medical advice provided by a licensed health care provider. Always consult your doctor before trying anything that you find online.