BEIJING (dpa-AFX) - Zai Lab Limited (ZLAB) Friday said that China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults.
The NDA submission is supported by positive results from a Phase 1 Pharmacokinetics study and a Phase 3 study of KarXT in China and global EMERGENT studies. The Phase 3 study and EMERGENT studies met their primary goals of statistically significant reductions in schizophrenia symptoms compared to placebo.
The drug is approved in the U.S. in September last year and is marketed under the brand name Cobenfy.
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