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China’s regulator approves novel narcolepsy type 1 therapy first
The NMPA cleared commercial sales for people aged 16 and older, ahead of US, Japan, and Europe authorities.
China’s National Medical Products Administration has approved a novel, globally trialled therapy for narcolepsy type 1, marking the first approval among the United States, Japan, and Europe, according to SCMP Economy. SCMP Economy reports that the NMPA said it granted the green light for commercial sales of the rare-disease treatment for patients aged 16 and older. The regulator’s head of chemical drugs registration, Xu Xiaoqiang, said the approval represents a historic breakthrough for first-in-class innovation, and that Chinese patients were included from the outset in international clinical trials. The drug was not named, but SCMP Economy says it had received fast-track designations in the US and orphan-drug designation in Japan and the European Union. Orphan-drug status can come with incentives such as tax breaks and exclusive rights intended to make development financially viable.
China’s approval comes as the country positions biopharmaceuticals as one of its growth engines, SCMP Economy added, with the therapy intended for a lifelong brain condition that causes intense daytime sleepiness and, for many sufferers, sudden loss of muscle control triggered by strong emotions.