FDA adcomm votes 12-1 against Levo Therapeutics' nasal spray for a disorder that causes insatiable hunger
The FDA’s Psychopharmacologic Drugs Advisory Committee on Thursday voted 12 to 1 against approving Levo Therapeutics’ nasal spray for Prader-Willi syndrome, a difficult-to-treat disease that leaves patients with constant, insatiable hunger.
Those who voted no raised concerns about a lack of substantial evidence, as a 9.6 mg dose of the drug failed the primary endpoints in a Phase III trial. Looking for a silver lining, Levo turned to a 3.2 mg dose which met the trial’s secondary endpoints. But adcomm members wondered whether Levo could replicate those positive results.
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