Eisai Co., has announced that the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has accepted for evaluation the Marketing Authorisation Application (MAA) for lemborexant, the company's in-house discovered and developed dual orexin receptor antagonist, for the treatment of adults with chronic insomnia.

The application covers adult patients experiencing insomnia symptoms for at least three months that significantly affect daytime functioning. Acceptance of the application marks an important regulatory milestone in Eisai's efforts to expand access to the therapy in the UK.

Lemborexant is a Dual Orexin Receptor Antagonist (DORA) that works by competitively binding to orexin receptor subtypes OX1R and OX2R, inhibiting orexin neurotransmission responsible for regulating sleep and wakefulness. By blocking these receptors, the therapy is designed to facilitate sleep onset while reducing nighttime wakefulness.

Chronic insomnia is characterised by persistent difficulty in falling asleep, staying asleep, or both, despite adequate opportunities for sleep over a period of at least three months. The condition is often associated with fatigue, impaired concentration, irritability and reduced daytime functioning, significantly affecting patients' quality of life.

According to Eisai, chronic insomnia affects an estimated 6.8 percent to 14.8 percent of adults in the United Kingdom, making it a significant public health concern. The company noted that there is growing demand for treatment options that not only improve sleep quality but also address the impact of insomnia on daytime performance.

If approved by the MHRA, lemborexant will offer an additional treatment option for adults living with chronic insomnia in the UK, expanding the range of therapies available to clinicians and patients.

Eisai said neurology, including sleep disorders, remains one of its key therapeutic focus areas. The company continues to invest in developing innovative treatments for diseases with significant unmet medical needs and aims to improve outcomes and quality of life for patients living with neurological disorders and their families.