FDA grants ocrelizumab 'breakthrough therapy designation...

[MSUK]

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

[1eye]

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?

[MSUK]

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.

[David1949]

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

[SarahLonglands]

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