FDA advisory committee supports approval of Sanofi's Lemtrada; questions trial conduct

An FDA advisory panel voted 17-0 with one abstention on Wednesday, recommending approval of Sanofi's Lemtrada (alemtuzumab) for the treatment of relapsing multiple sclerosis. However, the panel expressed concerns regarding the conduct of the clinical trials of the intravenous therapy, voting 11-6 with one abstention that the company's studies were insufficient to assess the drug’s effectiveness.

The FDA reviewers questioned whether Sanofi's clinical trials were "adequate and well-controlled." Panel member Robert Clancy said "if the study is biased, then everything that flows from the study can’t be trusted." However, the panel voted 12-6 that Sanofi's Genzyme unit provided substantial evidence that Lemtrada worked for patients with relapsing MS, although they voted 14-2 with two abstentions that the drug did not improve patient's disability.

Many panel members said that Lemtrada's safety issues shouldn't preclude its approval because patients should be allowed to make the decision about the risk/benefit ratio of the therapy. While panellists said the drug appeared to be effective against the disease, they also voted 16-0 with two abstentions that Lemtrada shouldn’t be a first-line treatment option for newly diagnosed patients. "For the foreseeable future, I would rank it as a third-line drug," remarked panel member Justin Zivin.

The panel's vote follows a report by FDA staff which said that Lemtrada's "multiple serious and potentially fatal safety issues" may outweigh its efficacy unless it demonstrated "substantial clinical benefit." The FDA is expected to make a decision on whether to approve the drug by December 27.

Bayer will co-promote the therapy, which analysts project could generate revenue of $672 million in 2017. Lemtrada was cleared in Europe in September for the treatment of adults with relapsing remitting MS.

For related analysis, read ViewPoints: Can Sanofi convince FDA on the benefits of Lemtrada?

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