LianBio Reports the NMPA Acceptance of NDA and Granted Priority Review of Mavacamten for Obstructive Hypertrophic Cardiomyopathy
Shots:
- The NDA was based on the P-III trial (EXPLORER-HCM) evaluating mavacamten vs PBO in 251 patients
- The trial met its 1EPs & 2EPs and also showed a robust treatment effect with clinical improvements in exercise capacity, functional status & PROs as well as the ability to relieve left ventricular outflow tract obstruction
- The NDA also contains clinical results from a P-I PK study of mavacamten in healthy Chinese volunteers which demonstrated a safety & tolerability profile, as well as a PK profile similar to P-I PK studies, carried out in the US. Blinded preliminary safety data from an ongoing P-III trial (EXPLORER-CN) of mavacamten also supported the early NDA filing & the results are anticipated in mid-2023
Ref: LianBio | Image: LianBio
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