Eisai announced Monday that the FDA approved Dayvigo (lemborexant) for the treatment of insomnia characterised by difficulties with sleep onset and/or sleep maintenance in adults. The company noted that the orexin receptor antagonist will be available by early April 2020 following scheduling by the US Drug Enforcement Administration, which is expected to occur within 90 days.
"We believe the approval…is particularly exciting because it is the first FDA-approved medication to report safety data over a 12-month period along with sleep onset and sleep maintenance efficacy data over a six-month period in a pivotal clinical study," remarked Lynn Kramer, chief clinical officer of Eisai's neurology business group. The company plans to market the drug alone in the US and has initiated talks with health insurers.
According to Eisai, authorisation of Dayvigo was based on results from a clinical development programme that included the pivotal Phase III SUNRISE 1 and SUNRISE 2 studies in a total of about 2000 adults with insomnia. In the trials, Dayvigo demonstrated significant superiorities on sleep onset and sleep maintenance compared to placebo in both subjective and objective evaluations. The company noted that across both studies, the drug was not associated with rebound insomnia following treatment discontinuation, and there was no evidence of withdrawal effects after discontinuation.
In March, Eisai submitted an application seeking approval of lemborexant in Japan, while a filing was submitted in Canada in August. Meanwhile, earlier in the year, Eisai bought out Purdue Pharma's rights to the global collaboration for the development and commercialisation of the drug. The Japanese drugmaker is also investigating the compound in other sleep disorders, including in patients with Alzheimer's disease.
Merck & Co.'s Belsomra (suvorexant) became the first orexin receptor antagonist available in the US following its approval by the FDA in 2014 to treat people with insomnia.
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