China gives market approval for new narcolepsy drug

China's National Medical Products Administration (NMPA) has become the first in the world to grant market approval for a new medication for narcolepsy.

The oral selective orexin receptor 2 agonist, known as TAK-861, is designed to treat type 1 narcolepsy — a chronic, rare disorder characterized by excessive daytime sleepiness. It is developed by the global pharmaceutical company Takeda.

The drug leverages a novel target and mechanism and was developed through multicenter global clinical trials. It has now been approved in China for the treatment of adult patients and adolescents aged 16 and above, according to the administration.

China's NMPA is the first such body to issue market authorization despite the fact that drug regulators from the European Union, Japan and the United States have all accepted marketing applications for the therapy and granted it priority review.

Historically, the vast majority of novel drugs have reached the market first in the United States or other developed countries.

China's approval of the drug signals a historic breakthrough in the development, registration and market launch of highly innovative treatment, said Xu Xiaoqiang, an official with the administration, during an interview with Central China Television.