FDA panel supports approval of Sanofi MS drug Lemtrada

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FDA panel supports approval of Sanofi MS drug Lemtrada

By Deborah Zabarenko SILVER SPRING (Reuters) - A federal advisory panel recommended approval of Sanofi SA's experimental multiple sclerosis drug Lemtrada on Wednesday, but said the drug should be reserved for patients who have failed other therapies. In a surprise decision, an advisory panel to the Food and Drug Administration voted 14 to 0, with one abstention, that the drug should be approved despite its potential to cause cancer and other serious conditions. No way!" said Dr. Nathan Fountain of the University of Virginia School of Medicine and the panel's chairperson. The panel's recommendation follows an initial report last week by reviewers for the FDA, who raised grave concerns about the drug's potential to cause an array of autoimmune conditions, in which the body mistakenly attacks its own cells, as well as its potential to cause thyroid, skin and breast cancer.

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