Sobi's TRYNGOLZA receives positive CHMP recommendation following Phase 3 results showing significant reductions in triglyceride levels and acute pancreatitis risk, paving the way for potential EU approval.
The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for TRYNGOLZA (olezarsen), which serves as a critical regulatory milestone for Sobi. This recommendation is underpinned by robust Phase 3 CORE and CORE2 clinical trial data, which showed a 72% reduction in triglyceride levels and an 85% decrease in acute pancreatitis events, significantly de-risking the asset's path to EU market authorization.
The drug demonstrated a 72% reduction in triglyceride levels and an 85% reduction in acute pancreatitis events in Phase 3 trials.
It is a positive regulatory recommendation that paves the way for potential EU marketing authorization for the drug.
Swedish Orphan Biovitrum (Sobi) secured a positive CHMP opinion for TRYNGOLZA (olezarsen), backed by Phase 3 trial data. The drug demonstrated a 72% reduction in triglyceride levels and an 85% decrease in acute pancreatitis events, signaling a major milestone for the company's cardiovascular pipeline.
The positive opinion from the Committee for Medicinal Products for Human Use (CHMP) is a critical regulatory step that typically leads to European Commission approval for marketing the drug in the EU.
In Phase 3 trials, the drug achieved a 72% reduction in triglyceride levels and an 85% reduction in the rate of acute pancreatitis events compared to a placebo.