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Crunch Time For Idorsia Insomnia Therapy As Reviews Begin

Daridorexant Is Swiss Company's First Drug

 
• By Kevin Grogan

The US FDA has accepted the Swiss biotech's "huge" NDA file for daridorexant which the company hopes will be more successful on the insomnia market than other DORA sleep treatments such as Merck & Co's Belsomra.

clozel
CEO Jean-Paul Clozel • Source: Idorsia

Idorsia Pharmaceuticals Ltd has moved a significant step closer to having its first therapy approved now that the US Food and Drug Administration has agreed to evaluate the closely watched sleeping pill daridorexant.

The agency has accepted the Swiss biotech's new drug application (NDA), which was filed on 8 January, and granted a standard review to daridorexant, a dual orexin receptor antagonist (DORA), for the treatment of adults with insomnia

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