Ramelteon works by selectively targeting two melatonin receptors in the brain MT1 and MT2 to regulate body’s sleep-wake cycle and treat insomnia.
TGRD Europe has withdrawn its Marketing Authorization Application (MAA) submitted to the European Medicines Agency (EMA) in March 2007.
After examining the possibility of filing a new MAA, which would include new clinical data generated since the original submission, Takeda decided not to re-submit the MAA.
Takeda remains committed to ramelteon and plans to conduct further research to assess the potential of ramelteon from every perspective.
Ramelteon was approved by the US Food and Drug Administration in July 2005 and the Japanese Ministry of Health, Labour and Welfare in April 2010, and is available in these countries as Rozerem.