Press Releases
September 26, 2008
Takeda Pharmaceutical Company Limited
Takeda to Withdraw its Marketing Authorization Application for Ramelteon for the Treatment of Primary Insomnia in Europe
Osaka, Japan, September 26, 2008 --- Takeda Pharmaceutical Company Limited ("Takeda") announced today that its wholly-owned subsidiary Takeda Global Research & Development Centre (Europe) Ltd. (London, United Kingdom; "TGRD (EU)") has withdrawn its Marketing Authorization Application (MAA) for ramelteon in Europe.
TGRD(EU) submitted the MAA for ramelteon in Europe in March 2007. The Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMEA), adopted a negative opinion recommending the refusal of a marketing authorization for ramelteon in May 2008. In response, TGRD(EU) requested a re-examination of the CHMP opinion in June 2008. However, upon analysis of additional clinical study data collected after the submission of this application, TGRD(EU) has concluded that a marketing authorization for ramelteon could be better supported at an early date by submission of new data via a new MAA. For this reason, TGRD(EU) has decided to withdraw the original application.
Takeda remains convinced of the positive aspect of ramelteon, which induces the natural sleep for the treatment of patients with primary insomnia. Takeda is determined to continue making an all-out effort to receive the authorization for marketing of this drug in Europe.
About Ramelteon
Ramelteon works by selectively targeting two melatonin receptors in the brain, MT1 and MT2, which are located in the suprachiasmatic nucleus, the body’s ‘master clock’. By acting on these receptors, the body’s sleep-wake cycle is regulated and the physiological sleep is promoted.
Ramelteon, marketed as ROZEREMTM in the United States, was approved by the US Food and Drug Administration in July 2005. It also has been filed as a New Drug Application with the Ministry of Health, Labour and Welfare in Japan.
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