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Harmony Gets Dissonant FDA Response For Wakix In Idiopathic Hypersomnia

 
• By Alaric DeArment

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.

refusing to file - 182843126 - shutterstock
• Source: Shutterstock

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.

The Plymouth Meeting, PA-based drug maker said 19 February that the FDA had sent it a refuse to file (RTF) letter in response to its application for Wakix as a...

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