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Tuesday, November 19, 2013

FDA advisory committee recommends Lemtrada’s approval with restrictions; final decision by FDA to come by year’s end

Posted by Editorial Team—November 14th, 2013

As discussed in Laura’s latest blog Lemtrada – Sanofi’s Request for a new MS Drug, the Food and Drug Administration is expected to make a decision regarding the approval of Lemtrada (alemtuzumab) for the treatment of Multiple Sclerosis later this year. An FDA advisory committee recently reviewed clinical trial results, including important safety data, to assess if Lemtrada should be available to patients with Multiple Sclerosis.
Yesterday the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee recommended approval of Lemtrada for patients with relapsing forms of MS despite serious side effects seen in clinical trials. The advisory panel specifically noted that it should be reserved for patients who have failed on other MS therapies. The panel was also asked to vote on a series or other topics concerning the medication, including effectiveness, overall safety, and a possible program that would be required to monitor the safety and side effects of Lemtrada over time.
The advisory committee discussed Lemtrada’s clinical program, including two phase 3 clinical studies in MS – CARE-MS 1 and CARE-MS 2. Highlights from these studies can be found hereMS Research UpdateThe CARE-MS 1 study, which was conducted in people with MS who were treatment-naive (patients who had not yet received a disease-modifying treatment) compared Lemtrada to Rebif (interferon beta-1a). The CARE-MS 2 study was conducted in people with RRMS who had had at least one relapse while receiving either interferon beta medication or Copaxone (glatiramer acetate). In both trials Lemtrada demonstrated patients were significantly less likely to experience a relapse over the course of two years than other drug. However, reviewers questioned whether the design of the trials resulted in more favorable and potentially biased results for Lemtrada. The panel ultimately voted that the studies were insufficient to assess Lemtrada’s effectiveness, but nonetheless recommended its approval with restrictions as noted above.
It is important to note that the FDA is not required to follow the advice of its advisory committees, though it often does. The FDA is due to make a final decision on Lemtrada later this year, and the product received approval in Europe earlier this year.
Lemtrada is a trademark of Genzyme, a Sanofi Company.
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