Takeda submits EU marketing application for insomnia drug

Takeda Pharmaceutical has announced that its subsidiary Takeda Global Research & Development Centre (Europe) has sumbitted a marketing authorisation application to the European Medicines Agency for ramelton, an insomnia treatment.

Application for approval of the primary insomnia treatment has been made to the regulatory authority through its centralised procedure.

Ramelton, the subject of 58 clinical trials in Europe, Canada, Japan and the US, operates through the targeting of the MT1 and MT2 melatonin receptors located in the suprachiasmatic nucleus in the brain.

The suprachiasmatic nucleus regulates circadian rhythms in the in the human body, with ramelton acting to regulate the sleep-wake cycle and promote physiological sleep.

Masaomi Miyamoto, general manager of the pharmaceutical development division of Takeda, said: “Since the discovery of ramelton in 1996, our company has been committed to exploring its effects in patients who have difficulty sleeping.”

He added that the company looked forward to bringing this next-generation treatment, the first specific MT1 and MT2 receptor agonist, to Europe.

Earlier this year, Takeda Global Research & Development Centre (Europe) announced that its fixed combination tablet of Actos (pioglitazone HCl) and glimepiride HCl, Tandemact, had received marketing authorisation from the European Commission.