Just weeks after getting the green light from the U.S. FDA, Japan’s Ministry of Health, Labor and Welfare has approved Takeda’s Ozeful tablets for the treatment of narcolepsy type 1.
Ozeful, which was developed by created by Takeda in its research laboratory in Japan, is an orexin 2 receptor (OX2R) selective agonist. It is now the only drug approved in Japan for the treatment of the disease itself, rather than for the management of individual symptoms associated with narcolepsy type 1. By stimulating OX2R, it treats orexin deficiency, therefore increasing wakefulness and reducing abnormal REM phenomena. This provides a holistic therapy rather than treating individual symptoms.
The approval in Japan marks the third approval for the drug worldwide. It was approved in China in July, and in the U.S. in early August, where it is currently under review by the U.S. Drug Enforcement Administration (DEA).