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

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