Takeda withdraws marketing application for insomnia drug in Europe

Takeda Global R&D Centre Europe (TGRD EU) submitted the marketing authorization application (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 said that it remains convinced of the positive aspect of ramelteon, which induces the natural sleep for the treatment of patients with primary insomnia.