Dawnzera FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 23, 2025.
FDA Approved: Yes (First approved August 21, 2025)
Brand name: Dawnzera
Generic name: donidalorsen
Dosage form: Injection
Company: Ionis Pharmaceuticals, Inc.
Treatment for: Hereditary Angioedema
Dawnzera (donidalorsen) is a prekallikrein-directed antisense oligonucleotide indicated for prophylaxis to prevent attacks of hereditary angioedema in adult and pediatric patients 12 years of age and older.
- Hereditary angioedema (HAE) is a rare and potentially life-threatening condition caused by mutations on the SERPING1 gene, resulting in deficient or dysfunctional C1-esterase inhibitor (C1-INH). C1-INH deficiency is associated with the overproduction of plasma kallikrein, which leads to the production of excess bradykinin, a potent vasodilator that causes abrupt increases in vascular permeability and angioedema attacks (episodes of severe swelling) in different parts of the body.
- Dawnzera contains donidalorsen, an RNA-targeted medicine that works to prevent excessive bradykinin production by lowering prekallikrein (PKK), a proenzyme for plasma kallikrein.
- FDA approval of Dawnzera was based on positive results from the Phase 3 global, multicenter, randomized, double-blind, placebo-controlled OASIS-HAE study in patients with HAE. The study met its primary endpoint, with DAWNZERA Q4W significantly reducing monthly HAE attack rate by 81% compared to placebo over 24 weeks.
- Dawnzera injection is administered subcutaneously every 4 weeks.
- Warnings and precautions associated with Dawnzera include hypersensitivity reactions including anaphylaxis.
- Common adverse reactions (incidence ≥ 5%) include injection site reactions, upper respiratory tract infection, urinary tract infection, and abdominal discomfort.
Development timeline for Dawnzera
Further information
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