Chelsea Wins U.S. Panel’s Backing for Fainting DrugAnna Edney
Chelsea Therapeutics International Ltd.’s shares almost doubled after winning the backing of U.S. advisers for a drug to prevent sudden drops in blood pressure, a boost for the company’s effort to bring its first product to market.
Chelsea climbed to $4.41 at the close in New York in its the largest one-day increase since Feb. 20. An advisory panel yesterday voted 16-1 to recommend U.S. regulatory approval for the drug, called Northera, in patients with nervous system disorders. A final ruling may come from the Food and Drug Administration by Feb. 14.
Neurogenic orthostatic hypotension, the cause of sudden blood pressure drops that can lead to dizziness and fainting, may affect as many as 300,000 people in the U.S. and Europe who typically have illnesses such as Parkinson’s disease. While an FDA staff report said the long-term effectiveness of Northera against the disorder was unclear, some panel members said there was evidence of short-term relief.
“I tend to lower the standard a little bit if there’s nothing else that really works,” said Michael Proschan, a panelist who is a mathematical statistician at the National Institute of Allergy and Infectious Diseases, after the vote.
Some panelists recommended approval be based on Chelsea proving Northera works longer than a week, which is as far as current data extends. When taken, Northera is converted into the hormone norepinephrine, which increases blood pressure, according to the FDA report.
The shares of the Charlotte, North Carolina-based company were halted yesterday while the advisers weighed whether to recommend the drug.
The FDA rejected Chelsea’s first attempt to bring Northera to market in March 2012, even after an advisory panel then voted to give the medicine its support based on unmet patient need. An FDA reviewer featured in the Jan. 10 report, Shari Targum, had questioned whether new data proved the drug worked better than a placebo after one week, the same issue FDA reviewers raised when Chelsea first sought Northera approval.