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news.Takeda Pharmaceutical has submitted a marketing authorization application for insomnia medication ramelteon, to the European Medicines Agency.
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Ramelteon works by acting on receptors which regulate the body's sleep-wake cycle, while other insomnia treatments work by depressing the central nervous system. Ramelteon was approved by the FDA in July 2005 and is being marketed by Takeda as Rozerem. The European brand name for ramelteon is yet to be confirmed.
Masaomi Miyamoto, general manager of the pharmaceutical development division of Takeda, said: “Ramelteon has a novel mechanism of action, the first specific MT1 and MT2 receptor agonist, which we believe will offer a new treatment option for people with insomnia. We look forward to bringing this next-generation treatment to Europe.”
Insomnia affects the daily life of around 20% of the European population, according to Takeda.