Biopharmaceutical company Zai Lab Limited (NASDAQ:ZLAB) (HKEX:9688) announced on Friday that China's National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for KarXT (xanomeline and trospium chloride) to treat schizophrenia in adults.
The NDA submission is supported by data from a Phase 3 study in China, which demonstrated statistically significant reductions in schizophrenia symptoms compared to placebo. KarXT also met all key secondary efficacy endpoints. Safety and tolerability were consistent with prior clinical trials.
In September 2024 the US Food and Drug Administration (FDA) approved COBENFY (xanomeline and trospium chloride) for the treatment of schizophrenia in adults.
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