ARTICLE | Clinical News
Rozerem ramelteon: Development discontinued
October 10, 2011 7:00 AM UTC
Takeda said its Takeda Global Research & Development (Europe) Ltd. subsidiary discontinued European development of ramelteon to treat insomnia "in order to best optimize Takeda's resources" for R&D. In 2008, Takeda withdrew an MAA for ramelteon to treat primary insomnia in adults. At the time, EMA said the withdrawal was based on Takeda's plan to consider seeking scientific advice on extending the clinical program for ramelteon to address CHMP's questions about the compound's benefit-risk profile (see BioCentury, Sept. 29, 2008). ...