Eisai Submits New Drug Application for DAYVIGO® (Lemborexant) in Hong Kong for the Treatment of Adult Insomnia
Eisai
Pharmaceutical Product R&D and Manufacturer
Tokyo, July 13, 2020 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo; CEO: Haruo Naito; hereinafter referred to as "Eisai") recently announced that the Department of Health of Hong Kong has accepted its new drug application for the approval of DAYVIGO, an orexin receptor antagonist developed in-house.®(Generic name: lemborexant) for the treatment of adult insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. This is DAYVIGO®First application submitted in Asia (excluding Japan). Eisai plans to continueSubmit Marketing Authorization Applications in More Asian Countries and Regions。
DAYVIGO®is a dual orexin receptor antagonist that competitively binds to both orexin receptors (OX1R and OX2R), inhibiting orexin neurotransmission and regulating the sleep-wake cycle. Blocking the binding of the wake-promoting neuropeptide orexin to receptors OX1R and OX2R is considered to inhibit the drive for wakefulness. DAYVIGO®Binds to orexin receptors OX1R and OX2R and acts as a competitive antagonist, with stronger inhibitory effects on OX2R, thereby suppressing both rapid eye movement (REM) and non-rapid eye movement (NREM) sleep drive; therefore, DAYVIGO is expected to®Can provide patients with faster sleep onset and sustained sleep effects.
June 2020, DAYVIGO®Approved in the United States for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance; DAYVIGO, a treatment for insomnia, was launched in Japan in July 2020.®。
Insomnia is characterized by difficulty initiating or maintaining sleep, or both, despite adequate opportunity for sleep, which may impair daytime functioning, such as causing fatigue, difficulty concentrating, and irritability.[1], [2]Insomnia is one of the most common sleep-wake disorders, with a high prevalence. Approximately 30% of adults worldwide experience symptoms of insomnia.[3], [4]It is reported that over 35% of adults in Hong Kong suffer from symptoms of insomnia.[5]The prevalence is particularly higher among the elderly, many of whom suffer from insomnia symptoms that persist for months or even years. Consequently, insomnia leads to various societal losses, such as prolonged absenteeism and reduced productivity. Insomnia also increases the risk of falls in the elderly.[6]
Eisai Will Continue to Strive to Provide DAYVIGO to Insomnia Patients in Asia®As a new treatment option, it helps insomnia patients restore daytime function and achieve recovery by enabling rapid sleep onset and high-quality sleep, thereby facilitating an active daytime life.
[Editor's Note]
1. About DAYVIGO®（Lemborexant）
DAYVIGO®It is a small-molecule compound developed internally by Eisai, which can bind to the dual orexin receptors OX1R and OX2R as a competitive antagonist (IC50values were 6.1 nM and 2.6 nM, respectively). Its mechanism of action in the treatment of insomnia is achieved through antagonism of dual orexin receptors. The dual orexin neuropeptide signaling system plays a crucial role in wakefulness. DAYVIGO®Binds to the dual orexin receptors OX1R and OX2R as a competitive antagonist, with stronger inhibitory effects on OX2R; since OX2R inhibition suppresses both rapid eye movement (REM) and non-rapid eye movement (NREM) sleep drive, DAYVIGO is therefore expected to®It can provide faster sleep onset and better sleep maintenance (Ki values: OX1R 8.1 nM, OX2R 0.48 nM).
June 2020, DAYVIGO®Approved for marketing in the United States for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance; in July 2020, DAYVIGO for the treatment of insomnia was launched in Japan.®. Furthermore, Eisai submitted DAYVIGO in Canada and Australia®New Drug Application.
Based on the results of clinical studies, DAYVIGO has been shown to®Not only for primary insomnia, but also for insomnia associated with other conditions (such as depression) (SUNRISE 2).
In addition to insomnia, a Phase II clinical study is being conducted in patients with mild-to-moderate Alzheimer’s disease dementia accompanied by Irregular Sleep-Wake Rhythm Disorder (ISWRD).
2. On Sleep-Wake Disorders and Insomnia
Sleep-Wake Disorders include categories of diseases such as insomnia, irregular sleep-wake rhythm disorder (ISWRD), hypersomnia, and respiratory-related sleep disorders. Among sleep-wake disorders, insomnia is the most common, with approximately 30% of adults worldwide experiencing persistent symptoms of insomnia.[3], [4]Insomnia disorder is characterized by difficulty initiating sleep, maintaining sleep, or both, despite having adequate opportunity for sleep. It leads to daytime consequences such as fatigue, difficulty concentrating, and irritability.[1], [2]
Good sleep quality is essential for physical health (including brain health)[7]. Studies have shown that the optimal sleep duration is 7–8 hours. Poor sleep can lead to various health consequences, such as an increased risk of hypertension, accidental injuries, diabetes, obesity, depression, myocardial infarction, stroke, dementia, and adverse effects on mood and behavior.[1], [8]。
Women are 1.4 times more likely to experience insomnia than men.[9]. The prevalence of insomnia is also high among the elderly; aging is often accompanied by changes in sleep patterns, including sleep fragmentation, frequent awakenings, and early morning awakening, leading to reduced sleep duration[10]。
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5. Wong, et. al. Prevalence of Insomnia among Chinese adults in Hong Kong: a population-based study. J Sleep Res. 2011; 20: 117-126
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