Eisai Submits NDA for Lemborexant (Dayvigo®) in China for the Treatment of Adult Insomnia

Today (January 11Day), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,Eisai Co., Ltd. applied for registration under Category 5.1Lemborexant TabletsThe listing application has been accepted. According to publicly available information from Eisai, lemborexant (brand name: Dayvigo) is aDual Orexin Receptor Antagonist, which has been previously approved for marketing in the Hong Kong region of China, for the treatment ofAdult insomnia, particularly difficulty falling asleep and/or maintaining sleep。

Screenshot source: CDE official website

Insomnia is one of the most common sleep-wake disorders, characterized byDespite having sufficient sleep time, many people still experience difficulty falling asleep, maintaining sleep, or both. This often affects their daytime condition, leading to fatigue, difficulty concentrating, irritability, and other symptoms. For many, insomnia can persist for months or even years. Additionally, insomnia increases the risk of falls among the elderly.

Lemborexant is a small molecule drug developed by Eisai.It competitively binds to two orexin receptor subtypes, OX1R and OX2R, inhibits orexin neurotransmission, and regulates the sleep-wake rhythm.The dual orexin neuropeptide signaling system plays an important role in wakefulness. As a competitive antagonist,LemborexantIt has a stronger inhibitory effect on OX2R and can suppress both REM and non-REM sleep drive.Thereby providing patients with faster sleep onset and better sleep maintenance.。

Lemborexant was previously approved in the United States and Japan in 2020 for the treatment of adult patients with insomnia, particularly those with difficulty falling asleep and/or maintaining sleep.In June 2021, Lemborexant was approved for marketing in Hong Kong, China.

It is reported that the approval of Lemborexant by the U.S. FDA was based on two pivotal Phase 3 trials involving nearly 2,000 adult patients with insomnia.Clinical Research(SUNRISE 1 and SUNRISE 2) results. The SUNRISE 1 study lasted for one month, with participants beingFemale adults aged 55 and above and male adults aged 65 and above who meet the diagnostic criteria for insomnia disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)SUNRISE 2 is a 6-month clinical study, with study participants beingPatients aged 18 years and above who meet the DSM-5 diagnostic criteria for insomnia disorder。The analysis of both studies showed thatLemborexant does not cause rebound insomnia.，There is also no evidence that withdrawal effects will occur after discontinuation of the drug, indicating that taking the medication for up to one year does not lead to physical dependence.。The most common adverse reaction in subjects was drowsiness.

In addition to treating insomnia,Lemborexant is also expected to be used in the treatment of other neurological disorders. According to Eisai's official website, the company is exploring this in the United States and Japan.Lemborexant for the treatment ofAlzheimer's Disease Dementia, which is currently in Phase 2 clinical trials.