LianBio-Licensed Camzyos Gets FDA Approval for Treatment of Hypertrophic Cardiomyopathy
LianBio said Friday that Bristol Myers Squibb got U.S. Food and Drug Administration approval for Camzyos mavacamten capsules for the treatment of adults with symptomatic class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms.
LianBio licensed rights for Camzyos from MyoKardia, now a wholly owned subsidiary of Bristol Myers Squibb, in August 2020 for the development and commercialization of Camzyos in mainland China, Hong Kong, Macau, Taiwan, Thailand and Singapore.
LianBio said Camzyos is the first and only FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of obstructive HCM.
The company is currently conducting a Phase 3 study designed to evaluate the safety and efficacy of mavacamten in Chinese patients with symptomatic obstructive HCM. Camzyos was granted Breakthrough Therapy Designation in China for the treatment of patients with obstructive HCM.
LianBio shares were up 8%, to $5.42, in premarket trading.
Apr 29, 2022