Chelsea Therapeutics blood pressure drug approved
WASHINGTON (AP) — The Food and Drug Administration on Tuesday approved a new drug from Chelsea Therapeutics to treat a rare blood pressure disorder that causes dizziness and fainting in patients with Parkinson's disease and similar conditions.
Shares of Chelsea Therapeutics Ltd. added 37 percent to $6.80 in after-hours trading.
Between 80,000 and 150,000 patients in the U.S. have the disorder, called neurogenic orthostatic hypotension.
The drug, known chemically as droxidopa, is the first FDA approval for Charlotte, N.C.-based Chelsea Therapeutics Inc., which has no other drugs on the market. Chelsea Therapeutics CEO Joe Oliveto said the company expects to launch Northera in the second half of 2014. The company has not yet priced the drug.
The approval marks a major comeback for the company and its drug. The FDA previously rejected the drug in March 2012, asking the company for an additional study to demonstrate Northera's effectiveness. Then last month FDA scientists raised serious questions about the drug's long-term effectiveness at a public meeting advisory panel meeting. FDA staffers said there was little data showing that the drug's benefits lasted beyond one week. FDA staffers also pointed to several issues that raise questions about the reliability of the company's studies, including a high drop-out rate among patients taking the drug.
FDA regulators approved the drug based on two-week clinical trials in which patients taking Northera reported less dizziness, lightheadedness and feelings of faintness than patients taking a placebo.
Chelsea is required to conduct long-term follow-up studies to establish the drug's long-term effectiveness.
The drug carries a boxed warning to alert doctors and patients to the risk of increased blood pressure while lying down, which can cause stroke.