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 -
