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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.
  • The company still expects the drug to generate sales of more than $800m this year from its narcolepsy indications.
  • Harmony plans to initiate a Phase III trial of high-dose pitolisant in IH later this year, a rare disease that has one approved drug and only a few others in clinical development.

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...

The Plymouth Meeting, PA-based drug maker said 19 February that the FDA refused to file its application for Wakix as a treatment for excessive daytime sleepiness (EDS) in adults with...

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