New Drug Application For In-House Developed New Anti-Insomnia Drug Dayvigo® Accepted In Hong Kong
First New Drug Application for Dayvigo in Asia outside Japan
TOKYO, July 8, 2020 - (JCN Newswire) - Eisai Co., Ltd. announced today that the new drug application for approval of its 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, has been accepted by the Hong Kong Department of Health. This application is the first application for DAYVIGO in Asia outside of Japan. Eisai plans to continue further applications for approval in respective Asian countries.
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). Blocking the binding of wake-promoting neuropeptides orexin to orexin receptors is thought to balance sleep-wake circuitry by suppressing excessive wake drive. 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 can be expected to provide faster sleep onset and better sleep maintenance to patients.
In June 2020, DAYVIGO was launched in the U.S. for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance; and in July 2020, DAYVIGO was launched in Japan for the treatment of insomnia.
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. 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 tend to 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 falling in older adults.(6)
Eisai will continue its efforts to deliver DAYVIGO as a new treatment option to insomnia patients in Asia, contributing to restoration of daytime function and recovery for patients with insomnia by delivering an active daytime life through fast sleep onset and good quality sleep.
Fo more information visit: https://www.eisai.com/news/2020/pdf/enews202037pdf.pdf.
(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)
Eisai Co., Ltd. defines our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. As a global pharmaceutical company, our mission extends to patients around the world through working with key stakeholders to improve access to medicines in developing and emerging countries.