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The CHMP has adopted a positive opinion recommending the indication extension of Sobi’s Tryngolza (olezarsen) as an adjunct to diet, in combination with other lipid-lowering therapies, for adults with severe hypertriglyceridemia (sHTG; fasting TG ≥880 mg/dL [≥10 mmol/L]); if confirmed, it would be the first & only RNA-targeted therapy authorised in the EU for this population, with an EC decision expected in Q4’26
Opinion was based on the P-III CORE (n=617) & CORE2 (n=446) studies, sponsored by Ionis with the TIMI Study Group, which met their 1EP with placebo-adjusted mean fasting TG reduction of up to 72% at 6mos., sustained through 12mos.; a pooled analysis showed an 85% reduction in adjudicated acute pancreatitis events over 12mos. vs PBO
Tryngolza is an RNA-targeted therapy that lowers apoC-III production, given SC once monthly via a pre-filled autoinjector; discovered & developed by Ionis, with Sobi holding exclusive commercialisation rights outside the US (excl. Canada & China)
Ref: Sobi | Image: Sobi & Ionis | Press Release
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The post Sobi and Ionis’ Tryngolza (Olezarsen) Receives the CHMP’s Positive Opinion for Severe Hypertriglyceridemia (sHTG) appeared first on PharmaShots.
