Sanofi has been boosted by the news that advisors to the US Food and Drug Administration have unanimously recommended approval of its multiple sclerosis treatment Lemtrada.
The agency’s Peripheral and Central Nervous System Drugs Advisory Committee voted in favour of Lemtrada (alemtuzumab), which came as a surprise to some observers given that last week FDA staffers spoke about “multiple serious and potentially fatal safety issues” linked to the drug. However, while the panel voted 12-6 that the drug provided substantial evidence of effectiveness, it went 14-2 (with two abstentions) that Lemtrada did not improve disability.
The committee voted 16-0 (with two abstentions) that the drug should not be indicated as a first-line therapy and 11-6 (one abstention) that the two studies Sanofi submitted as the basis for approval were not adequate and well-controlled.
The Boston Globe quoted panel member Robert Clancy of the University of Pennsylvania School of Medicine as saying while that the data did not justify approval as a first-line therapy, patients should have the right to make decisions about the risks and benefits of Lemtrada with their doctors. “There are individuals who know what their own circumstances (and) are willing to roll the dice”.
The first treatment course of Lemtrada is administered via intravenous infusion on five consecutive days, and the second course is given on three days, a year later. The drug got the green light in Europe in September.
