A new drug jointly developed and submitted for marketing approval globally in China, the US, Japan and other countries, has been approved for market launch in China first, and can be used for patients of “sudden sleep attacks,” China Central Television(CCTV) News reported Tuesday, citing National Medical Products Administration.
The orexin 2 receptor selective agonist, using new target and mechanism, is designed for type 1 narcolepsy patients aged 16 and above.
The approval marks a breakthrough for China in the global development of innovative drugs, from original target discovery and simultaneous international multi-center clinical trials to regulatory approval and market launch, CCTV News reported.
Narcolepsy is a chronic rare neurological disorder classified into two types. Its main symptom is uncontrollable sleepiness, with patients suddenly falling asleep while talking, eating or chatting. As a 24-hour sleep disorder, type 1 narcolepsy patients may also experience sudden loss of muscle control, known as cataplexy.
The disease has been included in China’s second national list of rare diseases, with an estimated global prevalence of about 4 in 10,000. Adolescents and children account for a relatively large proportion of patients, and the disease, often accompanied by multiple complications, can severely affect their study, work and daily life.
Experts said existing treatments for this rare 24-hour sleep disorder mainly focus on relieving symptoms, while new therapies targeting the causes of the disease are urgently needed. Currently approved drugs worldwide have limitations, including limited efficacy and potential risks such as chronic organ damage, psychological or physical drug dependence, and cognitive decline, according to the CCTV News.
The newly approved innovative drug underwent global multi-center clinical trials involving participants from 19 countries and regions, including adolescent patients. Clinical data showed that the drug can improve core symptoms of the disease and is expected to become a first-line treatment option in the future.
