aBLA Filing Intelligence & Biosimilar Opportunity

Andembry

Garadacimab-Gxii

Hereditary Angioedema Agents

Subcutaneous Injection

Andembry is a preventive therapy for hereditary angioedema (HAE) in adults and adolescents 12+ years. This selective Factor XIIa inhibitor targets the top of the inflammatory cascade with once-monthly dosing. FDA-approved in June 2025, offering the first monthly prophylactic HAE treatment targeting Factor XIIa.

Approval Date

16-Jun-25

Data Exclusivity Expiry

16-Jun-29

Market Exclusivity Expiry

16-Jun-37

Commercial snapshot

Market performance & projections

Revenue ($M)

151

CAGR (%)

32.83%

Projected sales, 2026–2032 ($M)

Analyst projection, $M per year

2026

234

2027

294

2028

364

2029

470

2030

498

2031

532

2032

568

Molecule profile

Details & specifications

Molecule

Garadacimab-Gxii

Innovator

CSL BEHRING LLC

Dosage Form

Subcutaneous Injection

Strength

200 mg/1.2 mL

Therapeutic Category

Hereditary Angioedema Agents

Usage

To prevent attacks of hereditary angioedema

Good to know

Frequently asked questions

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