NDA for insomnia drug lemborexant accepted by FDA

11 March 2019

Following swiftly on a Japanese filing, now the US Food and Drug Administration has accepted for review the New Drug Application (NDA) for lemborexant, an investigational agent being studied for the treatment of insomnia, a sleep-wake disorder.

A Prescription Drug User Fee Act (PDUFA) date is set for December 27, 2019. The drug was first filed for FDA review in mid-January this year.

The NDA submission, filed by Japan’s Eisai (TYO: 4523) and its partner Purdue Pharma was based on data from the clinical development program including two pivotal Phase III studies of lemborexant – SUNRISE 1 (Study 304) and SUNRISE 2 (Study 303).

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