Chelsea Therapeutics International Ltd. (CHTP) won the backing of U.S. advisers for its drug to prevent sudden drops in blood pressure, a boost for the company’s effort to bring its first product to market.
The drug, Northera, should be approved, the advisory panel voted 16-1 today at a meeting in Silver Spring, Maryland. The Food and Drug Administration, which isn’t bound by the recommendation, may decide by Feb. 14 on whether Northera can be sold to treat neurogenic orthostatic hypotension.
Chelsea shares had plunged 29 percent on Jan. 10 after an FDA staff report said that the company’s data didn’t answer questions the agency posed about long-term efficacy. Many panel members who voted in favor of approval said Chelsea showed the drug works short-term, and that initially is enough for such a rare, devastating disease with no other treatment options.
“I tend to lower the standard a little bit if there’s nothing else that really works,” Michael Proschan, a panelist who is a mathematical statistician at the National Institute of Allergy and Infectious Diseases, said after the vote.
Many panelists who voted in favor of the drug also recommended approval be conditioned on Chelsea proving Northera works longer than a week, which is as far as current data extends.
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 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.
Neurogenic orthostatic hypotension, which can cause sudden blood pressure drops and fainting, is common in the elderly and people with disorders such as Parkinson’s disease. Chelsea estimates almost 300,000 people suffer from the condition chronically in the U.S. and EU.
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