Unmet Need Is Not Enough: US FDA AdComm Rejects Levo’s Carbetocin For Prader Willi Syndrome

 
• By Brenda Sandburg

Patient representative was lone ‘yes’ vote, and even she acknowledged using a broad interpretation of ‘substantial evidence.’ The only route forward for Levo may be a new trial, though expanded access could be an option in the near term.

Hunger
Treatment for hyperphagia (unrelenting hunger) in Pader-WIlli sydrome gets negative review from FDA panel • Source: Alamy

Levo Therapeutics, Inc. may have to conduct another study if it wants to try to advance its nasal spray carbetocin for treatment of hyperphagia associated with Prader Willi Syndrome in light of the negative review of its data by a US Food and Drug Administration advisory committee.

The sponsor emphasized the intense unmet medical need for a treatment for the rare disease of unrelenting hunger, but the Psychopharmacologic Drugs Advisory Committee concluded 12-1 at its 4 November...

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