BRIEF—FDA to consider new sleep drug

The US regulator is proceeding to review a submission for Idorsia’s investigational dual orexin receptor antagonist, daridorexant, for adults with insomnia.

The New Drug Application (NDA) was submitted to the US Food and Drug Administration on January 8, 2021. If approved, the Swiss company anticipates launch in the USA in the first half of 2022.

The company submitted for marketing authorization in Europe on March 2, 2021.

Idorsia has already raised about $630 million to support registration and launch of the product, through a rights offering.

The product is believed to better existing options in this class by providing a reduced impact on daytime functioning, thereby improving safety.