Federal Drug Administration designates experimental therapy, ocrelizumab as ‘Breakthrough Therapy’ for treatment of primary-progressive MS

Genentech, a member of the Roche Group, announced in a February 16 press release that the experimental therapy ocrelizumab has been granted ‘Breakthrough Therapy designation’ by the U.S. Food and Drug Administration (FDA) for the treatment of people with primary-progressive MS.  This designation means that once Genentech files for approval of ocrelizumab to treat primary-progressive MS, the review process can be expedited.   According to the release, Genentech plans to pursue marketing approval for both primary-progressive MS and relapsing multiple sclerosis, and will submit data from three phase III studies to the FDA in the first half of 2016.

Breakthrough Therapy designation can expedite the development and review of therapies intended to treat a serious condition when clinical evidence indicates that the treatment may demonstrate substantial improvement over available therapy.  The designation was granted to ocrelizumab based on phase III trial results presented at the European Committee for Treatment and Research in MS in late 2015.  Compared to placebo, ocrelizumab significantly reduced the risk of progression of clinical disability by 24% in 732 people with primary-progressive MS. Read more about these results.

“An effective treatment for people with progressive MS would be truly life-changing,” said Dr. Alan Thompson, chair of the International Progressive MS Alliance Scientific Steering Committee. “We await the detailed safety and efficacy data with great anticipation, and thanks to this expedited review process we are very much looking forward to hearing of ocrelizumab’s future developments and implications.”


Read more on the ‘Breakthrough Therapy designation’ at the FDA website, and more on ocrelizumab at the National MS Society (NMSS) website.

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