Takeda withdraws European application for ramelton

Takeda Pharmaceutical has announced its wholly-owned subsidiary Takeda Global Research & Development Centre (Europe) has withdrawn its marketing authorisation application for ramelton in the EU.

The company submitted its application for the drug in March 2008, while the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a negative opinion recommending the refusal of authorisation for the drug in May 2008.

In response, Takeda requested a re-examination of this opinion by the committee in June 2008.

However, following analysis of further clinical study data collected by the firm after it submitted this application, Takeda concluded its application for the compound could be better supported by submitting new data to the regulator via a new marketing authorisation application.

“Takeda remains convinced of the positive aspect of ramelteon, which induces the natural sleep for the treatment of patients with primary insomnia,” the company said.

It added it is determined to continue to make the effort to receive marketing authorisation for this drug in Europe.

Last week, Takeda announced the establishment of a new company for clinical development, known as Takeda Clinical Research Singapore, with this unit to work closely with Takeda Pharmaceutical, Takeda Global Research & Development and Takeda Global Research & Development Centre (Europe).