SHANGHAI, CHINA, and PRINCETON, N. J., USA –
Media OutReach – 12 May 2023 – LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, announced yesterday that CAMZYOS
®(mavacamten) has received marketing approval for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) from the Pharmaceutical Administration Bureau of the Macau SAR.
“Hypertrophic cardiomyopathy is a cardiovascular disease that significantly impacts the quality of life of patients,” said Dr. Xiuhua Feng, Consultant of Cardiology at Kiang Wu Hospital. “We are very pleased to see the approval of mavacamten in Macau, as it will bring hope to local patients living with this chronic and debilitating condition.”
“Macau marks mavacamten’s first approval in LianBio’s licensed territories,” said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. “This approval is a major milestone for patients in the region and demonstrates LianBio’s commitment to accelerating patient access throughout Asia to innovative new treatments.”
In April 2023, the China National Medical Products Administration (NMPA) accepted with Priority Review the New Drug Application for mavacamten for the treatment of adults with symptomatic oHCM.
In April 2023, LianBio announced positive topline results from the Phase 3 EXPLORER-CN trial investigating mavacamten for the treatment of Chinese patients with symptomatic oHCM. EXPLORER-CN met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in Valsalva left ventricular outflow tract (LVOT) gradient from baseline to week 30 compared to placebo (p<0.001). Additionally, mavacamten demonstrated clinically important improvements for all secondary endpoints, including change from baseline to week 30 in resting LVOT peak gradient, proportion of participants achieving a Valsalva LVOT peak gradient <30 mmHg at week 30, proportion of participants achieving a Valsalva LVOT peak gradient <50 mmHg at week 30, proportion of participants with at least one NYHA class improvement from baseline to week 30, change from baseline to week 30 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS), and change from baseline to week 30 in left ventricular mass index evaluated by cardiac magnetic resonance imaging. Safety results in the trial were consistent with previous studies of mavacamten in symptomatic oHCM, and no new safety signals were reported.
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