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Text|Pharmaceutical Mission Hills
Today (August 26), the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China announced the latest announcement that Takeda's drug TAK-994 tablet is planned to be included in the list of breakthrough drugs for treatment Type 1 narcolepsy
Screenshot source: CDE official website
Orexin (orexin) is a neurotransmitter, usually considered to be the main regulator of the sleep-wake cycle
In early August, Takeda announced that the US FDA granted TAK-994 breakthrough therapy designation for the treatment of excessive daytime sleepiness in patients with type 1 narcolepsy
It is reported that the award of this breakthrough therapy is based on early and preliminary clinical data
At the same time, the intravenous infusion form of this drug, TAK-925, also showed the efficacy of keeping NT1 patients awake in the first phase of the proof-of-concept clinical trial
In China, a clinical trial application for TAK-994 was approved by CDE in September 2020
Image source: Screenshot of the official website of the drug clinical trial registration and information disclosure platform
Reference materials:
[1] Drug Evaluation Center of China National Medical Products Administration.
[2] Food and Drug Administration Grants Breakthrough Therapy Designation to Takeda's Investigational Compound, TAK-994, an Oral Orexin Agonist in Clinical Development for Narcolepsy Type 1 (NT1).
[3] Scanmmell (2001).
