TAKEDA FILES EUROPEAN APPLICATION FOR INSOMNIA DRUG

Takeda Pharmaceutical announced that its European R&D subsidiary has submitted a marketing authorization application to the European Medicines Agency for the company's insomnia medication, ramelteon.

Takeda markets ramelteon in the U.S. as Rozerem. The drug works by selectively targeting two melatonin receptors in the brain, MT1 and MT2, according to the company. These receptors are located in the suprachiasmatic nucleus, which regulates the sleep-wake cycle. This mechanism of action is different from other insomnia treatments, which work by depressing the central nervous system, Takeda said.

The European application was based on data collected from an extensive clinical research program that included clinical studies with 8,100 patients ages 18 to 93.

The company estimates that insomnia affects approximately 20 percent of the European population. Takeda said it believes there is an unmet need for insomnia treatment options with fewer side-effects and a low propensity for dependence.

The U.S. FDA approved Rozerem in July 2005.