Takeda Pharmaceutical Co has decided to discontinue development of its insomnia drug ramelteon in Europe, which is already on the market in the USA and Japan, due to regulatory requirements.
The Japanese drugmaker had been trying to get approval in Europe for the drug for some time. In September 2008, Takeda withdrew its application (filed in March 2007) to the European Medicines Agency's Committee for Medicinal Products for Human Use after the latter adopted a negative opinion some four months earlier.
Now, after examining the possibility of filing a new marketing authorisation application, which would include new clinical data generated since the original submission, the firm has decided not to re-submit. It says the decision "took into consideration European requirements for approval of compounds for the treatment of insomnia and Takeda’s long-term business strategy to optimise R&D efforts across its portfolio".
Ramelteon, sold as Rozerem, was approved by the US Food and Drug Administration in July 2005 and the Japanese Ministry of Health, Labour and Welfare in April 2010. It is not selling particularly well but Takeda says it believes ramelteon "represents a valuable treatment option" and it is "dedicated to conducting further research to evaluate the potential of ramelteon from every perspective".