The FDA has granted Breakthrough Therapy and Fast Track designations to Pitolisant for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy.

Harmony’s Chief Medical Officer, Jeffrey Dayno, MD, expressed his excitement over the drug’s designations in a recent statement. “We are very pleased that the FDA has granted pitolisant Breakthrough Therapy and Fast Track designations and believe it reflects the Agency’s interest in this investigational product to potentially address an important unmet medical need for patients with narcolepsy.

“We look forward to working with the FDA throughout the submission and review of an NDA for this first-in-class molecule with a novel mechanism of action to treat adult patients with narcolepsy with or without cataplexy.”

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