The U.S. Food and Drug Administration reviewers have "significant concerns" regarding the safety and efficacy of Sanofi's multiple sclerosis drug Lemtrada (alemtuzumab).
In a briefing document prepared for next week's advisory board meeting to discuss the drug's approval, one FDA reviewer reported that he the drug has "serious and potentially fatal safety issues." Specifically, in clinical trials, patients have developed a variety of autoimmune diseases as well as thyroid cancer and melanoma.
http://www.businessweek.com/news/201...fda-staff-says
In a briefing document prepared for next week's advisory board meeting to discuss the drug's approval, one FDA reviewer reported that he the drug has "serious and potentially fatal safety issues." Specifically, in clinical trials, patients have developed a variety of autoimmune diseases as well as thyroid cancer and melanoma.
http://www.businessweek.com/news/201...fda-staff-says
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