Posted by Michael Wonder on 24 Dec 2019
U.S. FDA approves Eisai's Dayvigo (lemborexant) for treatment of insomnia in adult patients
23 December 2019 - Orexin receptor antagonist proven effective for both sleep onset and sleep maintenance in clinical development program of more than 2,000 patients.
Eisai today announced that the U.S. FDA approved the new drug application for its in-house discovered and developed orexin receptor antagonist Dayvigo (lemborexant). Dayvigo was approved for the treatment of insomnia characterised by difficulties with sleep onset and/or sleep maintenance in adults. In the United States, Dayvigo will be commercially available in 5 mg and 10 mg tablets following scheduling by the U.S. Drug Enforcement Administration, which is expected to occur within 90 days.
The approval was based on the results of a clinical development program that included two pivotal Phase III studies (SUNRISE 2 and SUNRISE 1), which evaluated Dayvigo versus comparators for up to one month and Dayvigo versus placebo for six-months, respectively, in a total of about 2,000 adult patients with insomnia.
