Haegarda (C1 esterase inhibitor subcutaneous [human]) FDA approval

CSL Behring

23 June 2017 - CSL Limited today announced that the U.S. FDA has approved CSL Behring’s Haegarda (C1 esterase inhibitor subcutaneous [human]), the only subcutaneous therapy indicated for routine prophylaxis to prevent hereditary angioedema attacks in adolescent and adult patients. 

Hereditary angioedema (HAE) is a rare, genetic, and potentially life-threatening condition that causes painful, debilitating, and unpredictable episodes of swelling on the body, including the abdomen, face, larynx, and extremities.

Haegarda is a self-administered, plasma-derived concentrate of C1 esterase inhibitor (C1-INH) injected twice weekly subcutaneously.

Read CSL press release

Michael Wonder

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Michael Wonder

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Outcome , US , Orphan drug , Blood product