Chelsea Therapeutics International Ltd. failed to win U.S. regulatory approval for Northera, a drug to treat a cause of dizziness and fainting in people with nervous-system disorders.
The Food and Drug Administration requested data from an additional study of Northera, which can curb drops in blood pressure that trigger the symptoms, the company said today in a statement. The agency also suggested that if the drug were to gain approval, it may carry a so-called black box warning, the FDA’s strictest, related to a type of hypertension that could occur, the Charlotte, North Carolina-based company said.
An FDA reviewer last month recommended against Northera’s approval, linking it to a life-threatening neurological disorder and saying it wasn’t proven to work long-term. A panel of outside advisers voted Feb. 23 in favor of the drug because few treatments exist for the blood-pressure drop known as neurogenic orthostatic hypotension.
“We believe there continues to be an important unmet medical need in addressing the symptoms associated with neurogenic OH and remain committed to working with the FDA to determine the appropriate next steps required to bring a much needed new therapy to the market as quickly as possible,” said Simon Pedder, the company’s president and chief executive officer.
Chelsea Therapeutics is conducting a clinical trial that may provide the additional data about the drug’s “efficacy and durability” sought by the FDA, the company said in the statement.
The company’s shares dropped 27 percent to $2.67 in extended trading at 7:47 p.m. New York time. The stock declined 3.4 percent to $3.67 when regular trading was halted at 2:49 p.m. pending the announcement of the FDA’s decision.
About 180,000 patients in the U.S. suffer from the blood-pressure condition that leads to symptoms such as dizziness, becoming light-headed, blurred vision and fainting, Keith Schmidt, sales and marketing vice president for Chelsea Therapeutics told analysts on a Nov. 2 conference call.
Northera is available in Japan as part of a marketing agreement with Dainippon Sumitomo Pharma Co. and generates annual revenue of $50 million, Chelsea Therapeutics said on its website. The FDA is concerned that the drug has been associated with 28 reports of a life-threatening neurological disorder known as neuroleptic malignant syndrome in patients in Japan, agency reviewer Melanie Blank told advisers. The reports don’t contain enough detail to determine whether the condition is related to the drug, she said.
No incidents of the disorder have been reported in the company’s studies, Chelsea Therapeutics said in a Feb. 13 statement.