WASHINGTON, D.C. (
faces a big challenge Thursday -- convincing a panel of outside experts to look favorably on its hypotension drug Northera despite a damning FDA review that recommended against the drug's approval.
"On the basis of the safety concerns, compounded by absence of evidence of durability of effect, my regulatory recommendation is that we should not grant approval for droxidopa at this time," concluded FDA reviewer Melanie Blank in an FDA briefing document released Tuesday.
Droxidopa is the generic name for Northera.
Chelsea is seeking approval for Northera as a treatment for neurogenic orthostatic hypotension (NOH) -- a rare condition in which blood pressure drops dangerously low upon standing. The condition often strikes people who suffer from Parkinson's disease.
The FDA has convened a panel of experts who are meeting today to review the Northera clinical data. At the end of the meeting, the experts will vote on whether to not to recommend Northera's approval. The FDA will make a final approval decision on March 28.
Chelsea conducted a single clinical trial demonstrating "strong evidence" that Northera benefits NOH patients for at least one week, the FDA review states. However, FDA's reviewer said Northera's beneficial effect did not last long enough for patients, particularly in light of safety concerns, including 18 deaths that may or may not be tied to the drug.
Droxidopa is already approved in Japan for the treatment of NOH but FDA's review mentions nine reported cases of neuroleptic malignant syndrome (NMS), an often-fatal condition causing fever and rigid muscles tied to the drug's use.
For Chelsea to receive a positive vote Thursday, it will have to convince the expert panel that the endpoints and duration of the clinical trials used to assess Northera's clinical benefit were sufficient. Chelsea and FDA reached agreement in advance on these trial designs. Chelsea must also explain the patient deaths in the trial and show why Northera was not the cause.
Chelsea shares closed Wednesday trading at $2.41 and will be halted Thursday for the FDA panel. The stock has lost more than half its value since Feb. 13 when the company first disclosed the FDA's serious concerns about Northera.
--Written by Adam Feuerstein in Boston.
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