Takeda to appeal EMEA opinion on ramelton

Takeda has announced it is to appeal the negative opinion given to ramelton as a treatment for primary insomnia by the European Medicines Agency (EMEA).

Its wholly-owned subsidiary Takeda Global Research and Development Centre (Europe) has requested a re-examination of the opinion given by the agency’s Committee for Medicinal Products for Human Use (CHMP).

In May 2008, the CHMP recommended that marketing authorisation for the compound in this indication be refused in the EU as a result of concerns over a lack of effectiveness measured as the time to fall asleep.

The company notes the original marketing authorisation application was submitted by its European subsidiary in March 2007, with this request for re-examination being made in accordance to the formal process of the agency.

“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 that it looks forward to working in conjunction with the CHMP and EMA to bring this marketing authorisation application to a positive application for patients in the EU.

In March 2007, Takeda reported that ramelton was the subject of 58 clinical trials across Europe, the US, Canada and Japan.