Sanofi’s experimental multiple sclerosis treatment Lemtrada may not offer enough benefit to patients to outweigh its risks, U.S. regulators said. Lemtrada’s “serious and potentially fatal safety issues” may make the drug too dangerous to approve unless there is substantial clinical benefit, Food and Drug Administration staff said in a report today ahead of a Nov. 13 meeting of agency advisers to discuss the annual injection. The FDA is expected to decide whether to approve the medicine by the end of the year.
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