Sanofi receives China approval for Myqorzo and Redemplo
Sanofi has obtained marketing authorization from China's National Medical Products Administration for two innovative medicines: Myqorzo for obstructive hypertrophic cardiomyopathy and Redemplo for familial chylomicronemia syndrome.
Paris – Sanofi announced today that its two innovative medicines, Myqorzo (aficamten) and Redemplo (plozasiran), have received marketing authorization from China's National Medical Products Administration. Myqorzo is approved for the treatment of obstructive hypertrophic cardiomyopathy (oHCM), and Redemplo is approved for triglyceride reduction in adult patients with familial chylomicronemia syndrome (FCS) on the basis of dietary control.
Myqorzo is a selective, small-molecule cardiac myosin inhibitor designed to improve functional capacity and relieve symptoms in patients with oHCM, a condition characterized by abnormal thickening of the heart muscle. FCS is a rare and severe disease associated with extremely high triglyceride levels, increasing the risk of acute pancreatitis. Redemplo is a small interfering RNA (siRNA) medicine that targets the production of apolipoprotein C-III.
The approvals are based on positive pivotal Phase 3 clinical trials. The authorization for Myqorzo followed the SEQUOIA-HCM study, and the approval for Redemplo was based on the PALISADE study. Both studies demonstrated the efficacy and safety of the respective medicines for their indicated conditions.
These approvals underscore Sanofi's long-term commitment to China and its ambition to provide transformative treatments for patients with significant unmet medical needs. Sanofi previously secured exclusive rights to develop and commercialize Myqorzo in Greater China for both forms of HCM.