FDA grants ocrelizumab 'breakthrough therapy designation...

Discuss Ocrelizumab, a monoclonal antibody treatment for MS.
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MSUK
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FDA grants ocrelizumab 'breakthrough therapy designation...

Post by MSUK » Thu Feb 18, 2016 1:12 am

FDA grants ocrelizumab 'breakthrough therapy designation' for primary progressive MS

Roche Holding AG announced yesterday that it had received 'breakthrough therapy designation' from the U.S. Food and Drug Administration for the multiple sclerosis treatment ocrelizumab. This will likely speed up market authorisation in six to seven months instead of the usual 10 to 12 months...Read more - http://www.ms-uk.org/MSnews
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Re: FDA grants ocrelizumab 'breakthrough therapy designation

Post by 1eye » Thu Feb 18, 2016 6:02 am

There are a lot of things called "breakthroughs" covering many of the MSUK press releases. What about us SPMS patients? Divide and conquer again? Do you have to have some youth left for it to work?
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Re: FDA grants ocrelizumab 'breakthrough therapy designation

Post by MSUK » Thu Feb 18, 2016 6:12 am

Hi, 1eye,

Bit confused by your post.

Not sure what you mean, as these are not MS-UK related and are not press releases put out by ourselves. We are just reporting MS news stories as they are released on the internet.

With regards the 'Breakthrough Therapy Designation' this is an official FDA designation for certain new medical therapies.

Hope that clarifies things a little.
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Re: FDA grants ocrelizumab 'breakthrough therapy designation

Post by David1949 » Thu Feb 18, 2016 11:48 am

Note that the original source for this article is the Wall Street Journal.
Maybe the drug manufacturer just wanted to boost their stock price.

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Re: FDA grants ocrelizumab 'breakthrough therapy designation

Post by SarahLonglands » Thu Feb 18, 2016 1:29 pm

This is from Wikipedia:

In March 2010, Roche announced the suspension of clinical trials in rheumatoid arthritis and lupus erythematosus. This step followed excess deaths due to opportunistic infections. Development for multiple sclerosis continues.[6]

So, the trial was stopped due to too many deaths due to opportunistic infections, so what about people with MS? They can fall prey to opportunistic infections just as much! Sarah
An Itinerary in Light and Shadow Completed Dr Charles Stratton / Dr David Wheldon abx regime for aggressive secondary progressive MS in June 2007, after four years. Still improving with no relapses since starting. Can't run but can paint all day.

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