FDA approves Eisai's insomnia drug Dayvigo

23 December 2019
eisaibig

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.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Pharmaceutical