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Haegarda FDA Approval History

Last updated by Judith Stewart, BPharm on March 8, 2021.

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 for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in patients 6 years of age and older.

Development timeline for Haegarda

DateArticle
Sep 28, 2020Approval U.S. FDA Approves Haegarda (C1 Esterase Inhibitor Subcutaneous [Human]) for Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Patients (patients 6 years of age and older).
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

See also

Haegarda (C1 esterase inhibitor (human)) Consumer information

Further information

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