Approval of Dayvigo in Japan
On July 6th, 2020, Eisai announced that it had launched Dayvigo (lemborexant) in Japan for insomnia. The product was available in three different strengths: 2.5 mg, 5 mg, 10 mg tablets. The product has been added to the National health insurance drug list on April 22nd, 2020.
The approval is based on two pivotal Phase III clinical trials (SUNRISE 1 and SUNRISE 2) in adult patients with insomnia. SUNRISE 1 study conducted in North America and Europe, a significant improvement in the sleep onset latency was observed. Sleep efficiency and wake after sleep onset were the secondary endpoints, and a significant increase was observed compared to zolpidem. In the SUNRISE 2 trial, the statistically significant improvement observed in the primary (sleep onset latency) and secondary endpoints (subjective sleep efficiency and wake after sleep onset) compared to placebo.
Approval of Dayvigo in Hong Kong
On July 8th, 2020, the drug has approved by the Hong Kong Department of Health for insomnia.
Dayvigo is a dual orexin receptor antagonist and inhibits orexin neurotransmission. The drug is believed to facilitate sleep onset by inhibiting the orexin neurotransmission. In June 2020, the drug was approved in the US for insomnia.
Insomnia is characterized by difficulty in sleeping, which eventually leads to fatigue, challenges in concentrating, and irritability. It is estimated that 30% of patients have insomnia worldwide.