and have announced receipt of approval from the National Medical Products Administration (NMPA) of China for the supplemental biologics license application (sBLA) for VYVGART Hytrulo 1,000mg vial for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. This once-weekly 30-90-second subcutaneous (SC) injection reportedly marks the first and only approval in China for a therapy to treat this immune-mediated neuromuscular disorder of the peripheral nervous system. The gold standard of business intelligence.
The approval is based on the positive outcome of the randomised, double-blind, placebo-controlled multicentre ADHERE study. The trial comprised an open-label period to detect responders, followed by a randomised-withdrawal, double-blinded period to further evaluate the therapy. Patients from the Greater China region were enrolled in the ADHERE trial by Zai Lab, and the treatment response observed was in line with global study results.
A 69% reduction in the risk of relapse with VYVGART Hytrulo compared to placebo was shown in a subgroup analysis of Chinese individuals. Furthermore, 78% of Chinese individuals showed clinical improvement during the open-label period of the study. Access the most comprehensive Company Profiles on the market, powered by GlobalData.
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