Analyst questions mixed FDA advisory committee vote on Sanofi's Lemtrada

An analyst questioned the outcome of an FDA advisory panel meeting on Sanofi's Lemtrada (alemtuzumab), at which members voted 12-6 that the company provided substantial evidence of the drug’s effectiveness for treating patients with relapsing multiple sclerosis, but also voted 11-6 with one abstention that clinical studies weren’t conducted well enough to assess the therapy, Bloomberg reported Thursday. "That seems contradictory," remarked Deutsche Bank analyst Mark Clark.

"Either they were adequate and proved something, or they were inadequate and proved nothing," Clark said, adding "we’re somewhat confused." At the meeting, the committee also voted 14-2, with two abstentions, that Lemtrada did not improve patient's disability and 17-0 with one abstention that the drug's risks do not preclude approval. The FDA is scheduled to make a decision on whether to approve the injectable therapy by December 27.

"We are pleased that the advisory committee clearly recognised the effectiveness of Lemtrada and voted unanimously that the safety profile should not stand in the way of approval," Sanofi spokesman Jack Cox said."The committee vote did acknowledge FDA’s concerns around study design but this appears not to have had an impact on the committee’s votes of the effectiveness and safety profile of Lemtrada," Cox noted.

However, Jefferies analyst Jeffrey Holford suggested that "with the panel voting that the studies were not adequate and well-controlled, the FDA probably has to issue a [complete response letter]" that delays approval until Sanofi completes further work. "We continue to see the probability of approval at 20 percent to 30 percent," Holford added.

Lemtrada gained approval in Europe in September for the treatment of adults with relapsing remitting MS whose active disease is defined by clinical or imaging features. Bayer will co-promote the therapy, which analysts project could generate revenue of $672 million in 2017.

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

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