European Commission approves plozasiran for adults with FCS
The European Commission has granted marketing authorization for plozasiran as an adjunct to diet to reduce triglyceride levels in adults with familial chylomicronemia syndrome (FCS).
The European Commission (EC) has approved plozasiran, a small interfering RNA (siRNA) therapy targeting apolipoprotein C-III (APOC3), for the treatment of adults with familial chylomicronemia syndrome (FCS). The therapy is indicated as an adjunct to diet to reduce triglyceride levels in adults diagnosed with FCS based on either clinical criteria or genetic testing.
The approval is based on results from the phase 3 PALISADE trial, in which treatment with plozasiran 25 mg reduced triglyceride levels by approximately 80% from baseline. In a pooled analysis across all plozasiran dose groups, treatment was associated with an 83% reduction in the incidence of acute pancreatitis compared with placebo.
FCS is a rare genetic disorder characterized by severely elevated triglyceride levels and recurrent episodes of acute pancreatitis. The European Medicines Agency noted that the availability of plozasiran without the need for genetic confirmation may expand access to treatment for adults with clinically diagnosed FCS.