Arrowhead Pharmaceuticals (NASDAQ:ARWR) today announced that the Chinese National Medical Products Administration (NMPA) has approved REDEMPLO® (plozasiran) for the reduction of triglyceride levels in adult patients with familial chylomicronemia syndrome (FCS).
FCS is a severe and rare genetic disorder characterized by triglyceride levels that can be 10 to 100 times higher than normal, significantly increasing the risk of acute, recurrent, and potentially fatal pancreatitis.
Under an existing agreement, REDEMPLO will be marketed in Greater China by Sanofi.
Sanofi acquired the commercialization rights in 2025 from Visirna, a majority-owned Arrowhead subsidiary established to develop and commercialize four of Arrowhead’s investigational cardiometabolic medicines in the region.
The Chinese approval marks the third regulatory authorization for REDEMPLO, following recent approvals by the U.S. Food and Drug Administration (FDA) and Health Canada as an adjunct to diet to reduce triglycerides in adults with FCS.
The therapy is also under review for marketing authorization by additional regulatory authorities worldwide.
REDEMPLO is the first and only siRNA medicine approved by the FDA, Health Canada, and China’s NMPA for the treatment of FCS.
It offers patients a convenient at-home treatment option with a simple subcutaneous injection administered once every three months.