Is Donidalorsen approved by the US FDA?

Drugs@FDA lists 1 application product line for Donidalorsen, including DAWNZERA (AUTOINJECTOR) (Prescription).

Is Donidalorsen authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Donidalorsen: Dawnzera.

Active substance

Donidalorsen

US FDA 1
EMA 1

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
DAWNZERA (AUTOINJECTOR)	EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)	solution · subcutaneous	IONIS PHARMS INC	Prescription	21 Aug 2025

EMA European Union — centrally authorised medicines

Dawnzera Otsuka Pharmaceutical Netherlands B.V. · Authorised · authorised 19 Jan 2026 · ATC B06AC

Therapeutic indication (EMA)

Dawnzera is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.