Teva Pharmaceutical Industries Ltd. announced that the China National Medical Products Administration (NMPA) has approved AUSTEDO® (Deutetrabenazine Tablets) for the treatment of chorea associated with Huntington’s disease (HD) and Tardive Dyskinesia (TD) in adults, after a priority review. China is the second country in the world after the U.S. to have approved AUSTEDO.
AUSTEDO® is a vesicular monoamine transporter 2 (VMAT2) inhibitor.
As part of the expedited review process, the NMPA placed AUSTEDO on the List of Overseas New Drugs Urgently Needed in Clinical Settings (the First Batch) and granted it priority review, ultimately completing the approval process in four months for the benefit of Chinese patients. This is the second approval and expected launch in China of a Teva specialty medicine, following the recent launch of TREANDA. Teva will commercialize the medicine in China independently.
A rare and fatal neurodegenerative disorder, Huntington’s Disease has an overall prevalence rate in Asia of 0.40/100,000, with an average age at onset of 40 years...
Full text at GMPnews.Net