Swedish Orphan Biovitrum (Sobi) announces that Tryngolza (olezarsen) has been approved by the European Commission for the treatment of familial chylomicronemia (FCS), a rare disease that causes high triglyceride levels. The approval is based on positive results from the phase III BALANCE study, which showed significant reductions in triglycerides and a reduced risk of acute pancreatitis.
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Published September 19, 2025
Sobi's Tryngolza approved for FCS in the EU
Notes
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