Bristol Myers, LianBio's heart drug Camzyos meets main goal in Chinese patients study
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- Bristol Myers Squibb (NYSE:BMY) and LianBio's (NASDAQ:LIAN) drug Camzyos (mavacamten) met the main goal of a phase 3 trial in Chinese patients with a type of heart disease.
- LianBio was evaluating mavacamten in the study, dubbed EXPLORER-CN, to treat Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
- HCM is a condition in which the heart muscle becomes abnormally thick which can make it harder for the heart to pump blood.
- The trial met its main goal, showing a statistically significant and clinically meaningful improvement in Valsalva left ventricular outflow tract (LVOT) gradient from the time treatment started to week 30, compared to placebo.
- In addition, mavacamten showed improvement for all secondary goals, the company added.
- The drug showed a safety profile consistent with previous studies.
- Camzyos is currently under priority review in China and the filing was backed by data from a global phase 3 trial called EXPLORER-HCM and phase 1 pharmacokinetic study in healthy Chinese people.
- "With positive pivotal data now in hand and the NDA on file, we are optimistic about bringing mavacamten to market in China next year," said LianBio CEO Yizhe Wang.
- The U.S. FDA is expected to make a decision by June 16 on an expanded use of the drug based on data from a phase 3 trial called VALOR-HCM.
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