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Harmony Gets Dissonant US FDA Response For Wakix In Idiopathic Hypersomnia

 
• By Alaric DeArment

The agency sent the neuroscience-focused company a refuse-to-file letter for Wakix as a treatment for Idiopathic Hypersomnia, a disease with only one approved treatment and few others in development.

refusing to file - 182843126 - shutterstock
The FDA refused to file a supplemental NDA for Wakix in excessive daytime sleepiness in adults with IH. • Source: Shutterstock
Key Takeaways
  • The FDA sent a refuse-to-file letter to Harmony Biosciences for its sNDA seeking approval for Wakix in idiopathic hypersomnia, likely delaying launch to 2028 or later.

Harmony Biosciences plans to accelerate Phase III development of a high-dose pitolisant formulation (pitolisant HD) in idiopathic hypersomnia (IH) after...

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