Takeda submits MAA application for ramelteon

Osaka, Japan-based drugmaker Takeda has submitted a marketing authorization application for its drug candidate, ramelteon, to the European Medicines Agency (EMEA) for the treatment of primary insomnia. Ramelteon works by selectively targeting two melatonin receptors in the brain, MT1 and MT2, which help regulate the body's circadian rhythms, including the sleep-wake cycle. Takeda noted that this mechanism of action is different from existing insomnia drugs, which work by depressing the central nervous system. The drug was approved by the US Food and Drug Administration in July 2005 and is being marketed by Takeda Pharmaceuticals North America as Rozerem. Ramelteon's European brand name is yet to be confirmed.