New MS DMD Approved

[Sailorsong]

Late on Friday, May 27, 2016, the United States Food and Drug Administration announced the approval of Zinbryta™ (daclizumab) for adults with relapsing forms of multiple sclerosis (RMS). This monoclonal antibody is self-administered subcutaneously (under-the-skin) once per month and has been shown to reduce the number of relapses as well as new or newly enhancing lesions, as compared to another approved MS medication and to placebo, in two separate studies.

Zinbryta is the 14th disease-modifying therapy to be approved for the long-term treatment of relapsing forms of MS. The FDA states that this medication should only be used in patients who have had an inadequate response to two or more MS drugs. Zinbryta has a boxed warning and is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy.

[immisceo]

Yep, I have LFTs each month. The protocol was added to when I was in the middle of the phase III when a participant with an undisclosed preexisting liver ailment died. We were immediately informed (and given an updated contract to sign).

I wouldn't have any issue dropping it like a hot potato if my labs started coming back wonky. Five + years, so far so good. Obviously it will not be right for many people, but when it comes to MS modalities, I think the more the merrier.  

Dennis does raise an important point though. I hope PPMS has a DMD on the market soon!

[essdipity]

I'm glad if this drug has helped immi or anyone else, but for me it would be only a choice of last resort. Read about the 'boxed warning' and the potential for severe liver problems. In the US at least it requires blood testing before each dose and literally for years after discontinuing it because of its potential for liver damage. Sometimes this is worth it, but an informed choice is necessary.

[cjtmn]

I was so interested in this!! Then I saw that you have to have tried/failed 2 other drugs before this would be a consideration. Boo. :( Once a month sounds AWESOME to me!

[immisceo]

I think that one's ocrelizumab. Both are humanised monoclonal antibodies working on the immune system. It looks like it got its expedited designation in February. http://www.roche.com/investors/updates/inv-update-2016-02-17.htm

Unfortunately, "expedited" in research lingo is a whole other timeline than we'd all like. They've already submitted their Phase III data, have Breakthrough Therapy Designation and have their proprietary name picked out (OCREVUS), which is all sounds like approval is imminent-ish, so hopefully not too long a wait for everyone with PPMS.

[immisceo]

Thanks for posting this, Dennis! This is the drug I've been on for a few years in my drug study. My neurologist told me it was likely to be approved in 2016. I hadn't kept up with the news on it as the approval doesn't change my participation on the study and I don't live under FDA jurisdiction, but the relevant European body is likely to approve it now too.

For me, the modality is perfect. I think about my medication for about 90 seconds each month and don't have to worry about taking anything with me when I travel. It interferes with my everyday life not a jot!

[Sailorsong]

When I first saw the announcement I was hoping it was for the PPMS DMD that is suppose to be approved this year as it is on a fast track for approval. It sure would be nice to finally have something to treat my MS. LOL

Dennis

[cjtmn]

So good to hear, immi!!!

[suspiciouscombo]

Thx for sharing-