Friday, 30 May 2014

Alemtuzumab: Will the FDA be moved?

Will the FDA licence Alemtuzumab? #MSBlog #MSResearch

"Some news regarding alemtuzumab. The FDA has accepted Genzyme’s resubmission of Alemtuzumab for the treatment of relapsing forms of MS. A 6-month review period has been assigned and Genzyme expects an FDA decision before the end of the year. Please note that the resubmission is based on data from the same clinical studies included in the original submission, but provides supplemental analyses and additional information to specifically address issues previously noted by the FDA in its response to the alemtuzumab submission."

"I an quietly confident that the FDA will now license Alemtuzumab, which will save US MSers from having to travel abroad for treatment."

"The full press release can be read below."



CoI: multiple

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