trending Market Intelligence /marketintelligence/en/news-insights/trending/IoINxSDgDGaonD-0h5esOw2 content
Log in to other products

Login to Market Intelligence Platform

 /


Looking for more?

Contact Us

Request a Demo

You're one step closer to unlocking our suite of comprehensive and robust tools.

Fill out the form so we can connect you to the right person.

If your company has a current subscription with S&P Global Market Intelligence, you can register as a new user for access to the platform(s) covered by your license at Market Intelligence platform or S&P Capital IQ.

  • First Name*
  • Last Name*
  • Business Email *
  • Phone *
  • Company Name *
  • City *
  • We generated a verification code for you

  • Enter verification Code here*

* Required

In This List

Eisai insomnia drug Dayvigo wins US FDA approval

Gauging Supply Chain Risk In Volatile Times

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry

Segment

IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help

The Market Intelligence Platform


Eisai insomnia drug Dayvigo wins US FDA approval

Eisai Co. Ltd. said the U.S. Food and Drug Administration approved its drug Dayvigo for treating insomnia in adults.

The Tokyo-based drugmaker said the U.S. regulator gave the nod to Dayvigo, or lemborexant, as a therapy for insomnia characterized by difficulties with sleep onset and maintenance. Insomnia is the most common sleep disorder, affecting 30% of the adult population globally.

Lemborexant works by acting on the orexin neurotransmitter system, which regulates a person's wakefulness. Eisai was previously collaborating with Purdue Pharma LP on the medicine, but the Japanese company took over sole development of the drug in May after the latter became embroiled in a series of lawsuits over the U.S. opioid epidemic.

Eisai's application for Dayvigo was based on the results of two phase 3 trials called Sunrise 1 and Sunrise 2, which enrolled about 2,000 patients.

Eisai is also seeking Japanese and Canadian approval for Dayvigo.