Is alemtuzumab being misunderstood by the FDA? MSBlog #MSResearch
Anna Edney & Simeon Bennett. Sanofi’s Lemtrada Drug May Be Too Risky, FDA Staff Says. Bloomberg Nov 8, 2013 4:47 PM GMT
…. Alemtuzumab may not offer enough benefit to patients to outweigh risks including cancer, U.S. regulators said. Securities linked to the drug’s success plummeted……
…. Alemtuzumab’s “serious and potentially fatal safety issues,” which include the risk of autoimmune and thyroid diseases, may make the medicine too dangerous to approve unless there is substantial clinical benefit shown, Food and Drug Administration staff said in a report today. Agency reviewers also questioned whether Genzyme conducted adequate trials to prove the annual infusion works….
….. “The certainty of the risks of potentially lifelong hypothyroidism, serious infusion reactions, melanoma and other malignancies, Graves’s ophthalmopathy and other autoimmune disorders, and prolonged increased susceptibility to infection may not be balanced by the uncertainty that exists in the limited evidence of the potential clinical benefits from clinical trials that were not well-controlled,” FDA drug reviewer John Marler wrote in the report. ….
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