First Launch For Dayvigo In Asia Outside Of Japan
Eisai Co., Ltd. announced today that its Hong Kong subsidiary Eisai (Hong Kong) Co., Ltd. has launched the in-house-discovered and developed orexin receptor antagonist DAYVIGO (generic name: lemborexant) for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
Eisai received approval for DAYVIGO in Hong Kong on February 28, 2021, and this launch is the first for DAYVIGO in Asia outside of Japan.
DAYVIGO is a dual orexin receptor antagonist that inhibits orexin neurotransmission regulating sleep-wake rhythm by binding competitively to the two subtypes of orexin receptors (OX1R and OX2R). DAYVIGO acts on the orexin neurotransmitter system and is believed to facilitate sleep onset, sleep maintenance, and wake by regulating sleep-wake rhythm.
DAYVIGO binds to orexin receptors OX1R and OX2R and acts as a competitive antagonist with stronger inhibition effect on OX2R, which suppresses both REM and non-REM sleep drive, such that DAYVIGO may provide faster sleep onset and better sleep maintenance to patients.
DAYVIGO was launched in the U.S. and Canada for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance; and in Japan for the treatment of insomnia. In addition, applications for approval have been submitted to the respective regulatory authorities in Australia, Brazil, India, Indonesia, Malaysia, the Philippines, Singapore, Taiwan and Thailand, and Eisai plans to further expand submissions of applications for approval in other countries.
Insomnia is characterized by difficulty falling asleep, staying asleep or both, despite an adequate opportunity to sleep, that can lead to daytime consequences, such as fatigue, difficulty concentrating and irritability.1,2 Insomnia is one of the most common sleep-wake disorders. It is estimated that approximately 30% of adults worldwide have symptoms of insomnia.3,4 In Hong Kong, over 35% of adults are reported to have symptoms of insomnia.5 In particular, older adults also have a higher prevalence rate with many experiencing insomnia symptoms for months to years. As a result, insomnia causes various social losses, such as long absences and reduced productivity. It can increase the risk of falls in older adults. 6
Eisai will continue its efforts to deliver DAYVIGO as a new treatment option to insomnia patients across the world with the hope of contributing to restoration of daytime function and recovery for patients with insomnia by potentially delivering an active daytime life through fast sleep onset and good quality sleep.
About DAYVIGO (Generic Name: Lemborexant)
DAYVIGO, an orexin receptor antagonist, is Eisai’s in-house discovered and developed small molecule that inhibits orexin neurotransmission by binding competitively to the two subtypes of orexin receptors (orexin receptor 1 and 2). Fast on/off receptor kinetics of DAYVIGO to orexin receptors may influence DAYVIGO’s potential to facilitate improvements in sleep onset and maintenance with minimal morning residual effects.
About Sleep-Wake Disorders and Insomnia
Sleep-wake disorders consist of disease categories such as insomnia, Irregular Sleep Wake Rhythm Disorder (ISWRD), hypersomnia and breathing-related sleep disorders. Among the sleep-wake disorders, insomnia is the most common with persistent insomnia symptoms experienced by approximately 30% of the adult population worldwide.(3),(4) Insomnia disorder is characterized by difficulty falling asleep, staying asleep or both, despite an adequate opportunity to sleep, which can lead to daytime consequences, such as fatigue, difficulty concentrating and irritability.(1),(2)
Sleeping well is essential for good health, including brain health.(7) Studies suggest an optimal sleep duration between seven and eight hours.(8) Poor sleep is associated with a wide range of health consequences, including an increased risk of hypertension, accidental injury, diabetes, obesity, depression, heart attack, stroke, dementia and adverse effects on mood and behavior.(1),(8)
Women are 1.4 times more likely than men to suffer from insomnia.(9) Older adults also have higher prevalence of insomnia as aging is often accompanied by changes in sleep patterns, including disrupted sleep, frequent waking, and early waking, that can lead to less sleep time.(10)
About the Anti-Insomnia Drug Market in Hong Kong
The anti-insomnia drug market in Hong Kong as of 2020 valued at approximately 8.4 million USD, comprising nearly 9% of the insomnia drug market in Asia (Hong Kong, India, Indonesia, Korea, Malaysia, the Philippines, Singapore, Taiwan, Thailand).(11)
(1) Ferrie JE, et al. Sleep epidemiology – a rapidly growing field. Int J Epidemiol. 2011;40(6):1431-1437.
(2) Roth T. Insomnia: definition, prevalence, etiology and consequences. J Clin Sleep Med. 2007;3(5 Suppl):S7-S10.
(3) Institute of Medicine. Sleep disorders and sleep deprivation: An unmet public health problem. Washington, DC: National Academies Press. 2006.
(4) Ohayon MM, et al. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002;6(2):97-111.
(5) Wong, et. al. Prevalence of Insomnia among Chinese adults in Hong Kong: a population-based study. J Sleep Res. 2011; 20: 117-126
(6) National Institute of Public Health. Sleep disorders practice guidelines – for the proper usage of sleeping medications and the withdrawal: insomnia medical manual aiming for breaking through (available in Japanese only).
(7) Cappuccio FP, et al. Sleep duration and all-cause mortality: a systematic review and meta-analysis of prospective studies. Sleep. 2010;33(5):585-592.
(8) Pase MP, Himali JJ, Grima NA, et al. Sleep architecture and the risk of incident dementia in the community. Neurology. 2017;89(12):1244-1250.
(9) Roth T, et al. Prevalence and perceived health associated with insomnia based on DSM-IV-TR; International Statistical Classification of Diseases and Related Health Problems, tenth revision; and Research Diagnostic Criteria/International Classification of Sleep Disorders, second edition criteria: results from the America Insomnia Survey. Biol Psychiatry. 2011;69:592- 600.
(10) Crowley K. Sleep and sleep disorders in older adults. Neuropsychol Rev. 2011;21(1):41-53.
(11) Copyright 2021 IQVIA.Internal analysis based on IQVIA Analytics Link 2020. Reprinted with permission.