MHRA (UK) accepts marketing authorisation application for lemborexant for the treatment of adult patients with insomnia – Eisai

Eisai Co., Ltd. announced that the United Kingdom’s (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has accepted for evaluation a marketing authorization application (MAA) for its in-house-discovered and developed orexin receptor antagonist lemborexant for the treatment of adult patients with insomnia, characterised by symptoms present for at least 3 months with considerable impact on daytime functioning.

Lemborexant is a dual orexin receptor antagonist (DORA) that inhibits orexin neurotransmission regulating sleep and wake states by binding competitively to the two subtypes of orexin receptors (OX1R and OX2R). Lemborexant acts on the orexin neurotransmitter system, which regulates wakefulness. Lemborexant is believed to facilitate sleep onset and decrease wakefulness during the night by blocking the orexin receptors.

Chronic insomnia is characterized by difficulty falling asleep, staying asleep, or both despite an adequate opportunity to sleep for at least three months, and which can lead to fatigue, difficulty concentrating and irritability. In the U.K., chronic insomnia is reported to affect approximately 6.8–14.8% of adults and is recognized as an important health concern with a considerable impact on patients’ quality of life and daily activities. There is an increasing demand for treatment options that take into account their impact on daytime functioning. If approved, lemborexant will represent another treatment option for insomnia patients in the U.K.