Chelsea’s Data on Fainting Drug Is Inadequate, FDA Says
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Chelsea Therapeutics International Ltd.’s new data on its drug for preventing sudden drops in blood pressure falls short of what’s needed for approval, U.S. regulators said. The company sank the most in 13 months on the setback to its effort to bring its first treatment to market.
The data doesn’t answer questions the Food and Drug Administration posed about the efficacy of the medicine called Northera, agency staff said in a report posted today. FDA advisers plan to meet Jan. 14 to weigh approval of the therapy.