FDA approves Eisai's insomnia drug Dayvigo

The US Food and Drug Administration has approved the New Drug Application (NDA) for the orexin receptor antagonist Dayvigo (lemborexant), ahead of the Prescription Drug User Fee Act (PDUFA) date set for December 27, 2019.

Dayvigo, developed in-house by Japanese drug major Eisai (TYO: 4523), was approved for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults. Eisai’s shares closed today’s trading up just over 1% at 8,240 yen.

In the USA, Dayvigo will be commercially available in 5mg and 10mg tablets following scheduling by the US Drug Enforcement Administration (DEA), which is expected to occur within 90 days.