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FDA Medication Tracker

← All approvals · Rare & genetic · 2025

Dawnzera (donidalorsen)

The FDA approved Dawnzera (donidalorsen) on August 21, 2025 to prevent attacks of hereditary angioedema.
Brand name
Dawnzera
Generic name
donidalorsen
FDA approval date
August 21, 2025
Approved use (FDA wording)
To prevent attacks of hereditary angioedema
Company
Ionis Pharms Inc.
Application
NDA219407
Dosage form / route
SOLUTION · SUBCUTANEOUS
Boxed warning on label
Not listed
Category on this site
Rare & genetic

Indications and usage, from the FDA label

DAWNZERA™ is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. DAWNZERA is a prekallikrein directed antisense oligonucleotide indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.