Chelsea’s Data on Fainting Drug Is Inadequate, FDA Says

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.

The FDA rejected Northera in March 2012, sending the company what’s known as a complete response letter, and asked for an additional study to ensure the drug works over an extended period of time. Chelsea resubmitted the medicine for FDA review in July and the FDA is expected to decide whether to approve Northera by Feb. 14.

“This reviewer recommends a Complete Response action for droxidopa in the treatment of symptomatic neurogenic orthostatic hypotension (NOH), because of inadequate evidence of effectiveness,” Shari Targum at the FDA wrote in the most-recent review dated December 2013 in the report.

Chelsea fell 29 percent to $2.50 at the close in New York, in its biggest single-day drop since December 2012. The Charlotte, North Carolina-based company has more than doubled in the past 12 months.

300,000 People

The blood pressure drop is known as neurogenic orthostatic hypotension, which is common in the elderly and people with disorders such as Parkinson’s disease. Chelsea Therapeutics estimates almost 300,000 people suffer from the condition chronically in the U.S. and EU.

Targum’s review questioned whether the new data proved the drug worked better than a placebo after one week, the same issue FDA workers raised when Chelsea first sought Northera approval. A 2012 review that doesn’t consider the new data from FDA’s Melanie Blank makes five arguments in favor of clearing the drug for sale and seven arguments against, including the lack of durable effect.

FDA workers raised concern before the 2012 advisory panel meeting that Northera may also be linked to a life-threatening neurological disorder based on unsubstantiated reports of the condition associated with the drug’s use in Japan, where it’s available as part of a marketing agreement with Dainippon Sumitomo Pharma Co. While new data didn’t reveal any clearly defined cases of the disorder, Chelsea’s database may not be large enough to exclude such a rare side effect, FDA’s Targum wrote.

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