Ionis Pharmaceuticals Receives Approval Recommendation for Tryngolza's Indication Expansion in EU

MT Newswires Live10-16 19:06

Ionis Pharmaceuticals (IONS) received an approval recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, for Tryngolza's indication extension to include the treatment of adult patients with severe hypertriglyceridemia, the company said Friday.

The CHMP's positive recommendation was based on the results of two phase 3 studies that met their primary endpoint of demonstrating a significant reduction in fasting triglyceride levels, Ionis said.

Ionis also noted that the recommendation came earlier than expected, with the European Commission's final decision expected in Q4.

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