Takeda : to Appeal EMEA Negative Opinion on ramelteon for the Treatment of Primary Insomnia

June 17, 2008 – Takeda Pharmaceutical Company Limited (“Takeda”) announced that its wholly owned subsidiary, Takeda Global Research & Development Centre (Europe) Ltd. (“TGRD(EU)”), has requested a re-examination of the opinion given by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).

This request is in response to the negative opinion of May 30, 2008, in which the CHMP recommended the refusal of the marketing authorization in the EU for ramelteon in the treatment of patients with primary insomnia, since the CHMP was concerned that the effectiveness of ramelteon had not been demonstrated, which was measured considering only one aspect of insomnia, the time to fall asleep... Takeda's Press Release -

Takeda, New Drug Application for Ramelteon in Japan for

February 29, 2008 - Takeda Pharmaceutical Company Limited (“Takeda”) announced its submission of a New Drug Application of ramelteon for treatment of insomnia to the Ministry of Health, Labour and Welfare in Japan.
Ramelteon works by selectively targeting two melatonin receptors in the brain, MT₁ and MT₂. These receptors are located in suprachiasmatic nucleus, a body’s ‘master clock’, which regulates circadian (24-hour) rhythms, including the sleep-wake cycle. By acting on these receptors, body’s sleep-wake cycle is regulated and physiological sleep is promoted... Takeda's Press Release -