FDA panelists' opinions about the benefits of hypotension drug Northera clashed with those in an FDA staff review of the drug, and the agency's advisory committee backed the treatment for U.S. approval. Shares of Chelsea Therapeutics International ($CHTP), the drug's developer, rallied in after-market trading and were up 73% early this morning.
The non-agency experts on the FDA panel voted 7-4 in favor of approval Thursday, deciding that the benefits of the drug for treating symptomatic neurogenic orthostatic hypotension outweighed the risks that were highlighted in the FDA staff review earlier this week, Reuters reported. Despite cases of deadly neuroleptic malignant syndrome in patients who took the drug in Japan, where the drug has been in use for decades, FDA panel members weighed heavily the lack of any effective treatments for the chronic disease in the U.S.
"If there were other treatments available, the answer would be 'no.' But there aren't," said panelist Allan Coukell of Pew Charitable Trusts, as quoted by Reuters.
While the FDA doesn't have to follow suit with the panel in its ultimate decision on Northera's U.S. approval, investors appeared to be betting up the odds of Chelsea winning the agency's nod and bringing its first product to market. And the Charlotte, NC-based drug developer is poised to recover from the big hit its stock took after the agency staff review said loud and clear Tuesday that the drug shouldn't be approved.
The FDA is expected to decide by March 28 the fate of Chelsea's drug, which aims to combat the blood-pressure drop in some 180,000 patients with the disorder, Bloomberg reported. The symptoms of the disease such as dizziness and fainting can force some patients into wheelchairs.
- here's the Reuters article
- see Bloomberg's report