Skip to Content

Haegarda FDA Approval History

FDA Approved: Yes (First approved June 22, 2017)
Brand name: Haegarda
Generic name: C1 esterase inhibitor (human)
Dosage form: Subcutaneous Injection
Previous Name: CSL830
Company: CSL Behring
Treatment for: Hereditary Angioedema

Haegarda (C1 esterase inhibitor (human)) is a low-volume subcutaneous (SC) C1-esterase inhibitor (C1-INH) replacement therapy to prevent Hereditary Angioedema (HAE) attacks.

Development Timeline for Haegarda

Sep 28, 2020Approval U.S. Food and Drug Administration Approves Haegarda (C1 Esterase Inhibitor Subcutaneous [Human]) for Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Patients
Jun 23, 2017Approval FDA Approves Haegarda - First Subcutaneous C1 Esterase Inhibitor for Hereditary Angioedema
Aug 30, 2016FDA Accepts CSL Behring's BLA for First Subcutaneous Prophylactic Therapy CSL830 to Prevent Hereditary Angioedema Attacks

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.