Ionis Pharmaceuticals Says Dawnzera Recommended for Approval in EU for Hereditary Angioedema

MT Newswires Live

Nov 14, 2025

Ionis Pharmaceuticals (IONS) said Friday that it has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for Dawnzera to prevent recurrent attacks of hereditary angioedema in patients aged 12 years and older.

The company said the opinion was based on results from phase 3 studies in which Dawnzera demonstrated a "significant and sustained reduction" in mean monthly hereditary angioedema attack rate, including when self-administered via autoinjector.

The European Commission is expected to take a decision in Q1 of 2026, the company said.

Shares of Ionis Pharmaceuticals were down more than 3% in recent premarket activity Friday.

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