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Sobi receives positive CHMP opinion for TRYNGOLZA® (olezarsen) for the treatment of severe hypertriglyceridemia (sHTG)

Barchart·10/16/2026 06:12:00
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STOCKHOLM, Oct. 16, 2026 /PRNewswire/ -- Sobi® today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the indication extension for TRYNGOLZA® (olezarsen) as an adjunct to diet, in combination with other lipid-lowering therapies, for the treatment of adult patients with severe hypertriglyceridemia (sHTG, fasting levels of ≥880 mg/dL [≥10 mmol/L]). If confirmed by the European Commission (EC), TRYNGOLZA would be the first and only RNA-targeted therapy authorised in the EU for adults with sHTG and triglyceride levels ≥880 mg/dL (≥10 mmol/L). The positive CHMP opinion comes ahead of Sobi's previously anticipated timeline, with a final EC decision expected in the fourth quarter of 2026.

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