FDA Approval of DAWNZERA™ for Hereditary Angioedema

Ionis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved DAWNZERA™ (donidalorsen) for the prophylaxis of hereditary angioedema (HAE) in patients aged 12 and older. DAWNZERA is the first RNA-targeted medicine approved for HAE, designed to target plasma prekallikrein, a key protein involved in HAE attacks. The approval was based on positive results from the Phase 3 OASIS-HAE study, which showed an 81% reduction in monthly HAE attack rates compared to placebo. DAWNZERA can be self-administered every four or eight weeks, offering the longest dosing interval available for HAE treatment. The drug demonstrated a favorable safety profile, with the most common adverse reactions being injection site reactions, upper respiratory tract infections, urinary tract infections, and abdominal discomfort. Ionis plans to launch DAWNZERA in the U.S. shortly and will provide support services through its Ionis Every Step™ program.