Once partners with the now-embattled Purdue on an insomnia treatment, Eisai bought a full stake in the drug earlier this year––taking on its full development and marketing costs, too. Now, with an FDA approval in hand, Eisai is scaling up to support that drug's pending launch.
The FDA approved Eisai's Dayvigo (lemborexant) on Friday as a treatment for insomnia characterized by difficulties with sleep onset or maintenance.
Due to the FDA recommending the drug's classification as a controlled substance, Eisai plans to launch once Dayvigo receives a Drug Enforcement Administration schedule in roughly 90 days, the company said in a release.
Eisai took full ownership of Dayvigo in May after it bought out Purdue's stake in the drug in 2015. The drug is an orexin receptor antagonist that works by targeting the wake center of the brain, according to Eisai CEO and president of its global neurology business Ivan Cheung, who called the approval "very exciting."
"It’s a large opportunity, and the question now is differentiation," Cheung said. "There’s a lot of unmet need as far as efficacy and safety."
