MHRA Starts Evaluation of Eisai’s Lemborexant for Adult Insomnia

Eisai Co., Ltd. announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency has accepted for evaluation the company’s Marketing Authorization Application (MAA) for lemborexant (Dayvigo), its in-house discovered and developed dual orexin receptor antagonist (DORA), for the treatment of adult patients with insomnia characterised by symptoms present for at least three months with considerable impact on daytime functioning.

Acceptance of the MAA marks the initiation of the MHRA’s scientific assessment of the application and represents an important regulatory milestone toward the potential approval of lemborexant in the United Kingdom.

Chronic Insomnia Remains a Significant Public Health Concern

Chronic insomnia is characterised by difficulty falling asleep, staying asleep, or both despite an adequate opportunity to sleep for at least three months. The condition can lead to fatigue, difficulty concentrating, irritability, impaired daytime functioning, and reduced quality of life.

According to Eisai, chronic insomnia affects approximately 6.8% to 14.8% of adults in the United Kingdom, making it an important public health concern. The company noted that there is increasing demand for treatment options that take into account their impact on daytime functioning. If approved, lemborexant would provide an additional treatment option for adults with insomnia in the United Kingdom.

Lemborexant Targets the Orexin Wakefulness Pathway

Lemborexant is a dual orexin receptor antagonist (DORA) that competitively binds to the two orexin receptor subtypes, OX1R and OX2R, thereby inhibiting orexin neurotransmission that regulates sleep and wake states. By blocking the orexin neurotransmitter system, the medicine is believed to facilitate sleep onset and decrease wakefulness during the night.

According to Eisai, lemborexant also demonstrates fast on/off receptor kinetics, which may influence its potential to improve sleep onset and maintenance with minimal morning residual effects.

Global Regulatory Experience

Lemborexant has been approved for the treatment of insomnia in more than 25 countries and regions, including Japan, the United States, Canada, Australia, and China. Approval in the United Kingdom would further expand access to the medicine for patients with insomnia.

Eisai Reaffirms Commitment to Neurology

Eisai considers neurology, including sleep disorders, to be one of its therapeutic areas of focus. The company stated that it is committed to developing innovative medicines for diseases with high unmet medical needs and to increasing the benefits provided to people living with neurological disorders and their families.

Regulatory Path

With the application now accepted for evaluation, the MHRA will conduct its scientific review of the submitted data before reaching a regulatory decision on the marketing authorization application.

A positive decision would make lemborexant available as an additional treatment option for adults with insomnia in the United Kingdom, adding to its existing approvals in more than 25 countries and regions.

Reference

Marketing Authorization Application for In-house Developed Insomnia Drug Lemborexant Accepted for Evaluation by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA)