Sobi and Ionis win EU approval for Tryngolza in FCS
Swedish Orphan Biovitrum (STO: SOBI), known as Sobi, and Ionis Pharmaceuticals (Nasdaq: IONS) announced that Tryngolza (olezarsen) has been approved in the European Union (EU) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS).
The approval follows the positive opinion of the Committee for Medicinal Products for Human Use.
The approval is based on positive data from the Phase III Balance study, in which Tryngolza 80 mg demonstrated a statistically-significant reduction in fasting triglyceride levels at six months that was sustained through 12 months. Additionally, Tryngolza demonstrated a substantial and clinically-meaningful reduction in acute pancreatitis events over 12 months. Tryngolza showed a favorable safety and tolerability profile.
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