Harmony Biosciences plans to accelerate Phase III development of a high-dose pitolisant formulation (pitolisant HD) in idiopathic hypersomnia (IH) after the US Food and Drug Administration turned down its supplemental new drug application for marketed Wakix (pitolisant), which likely will delay Harmony’s entry into the IH market until 2028 or later.
Harmony Gets Dissonant FDA Response For Wakix In Idiopathic Hypersomnia
The agency sent the neuroscience-focused company a refuse-to-file letter for the drug as a treatment for IH, a disease with only one drug approved and few in development.
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