Haegarda Receives Expanded Indication for Hereditary Angioedema

September 28, 2020 – The U.S. FDA has approved an expanded indication for Haegarda® [C1 esterase inhibitor (human)], manufactured by CSL Behring. The drug is now indicated to provide routine prophylaxis against hereditary angioedema (HAE) attacks in patients who are at least six years old. It was previously indicated for use in patients age 13 and up.

HAE is a rare genetic disorder that causes painful and potentially life-threatening episodes (HAE attacks) of swelling. These episodes often affect the feet, hands, face, and genitals, but can also occur in areas such as the lungs, airways, and intestinal walls. Many factors can trigger an HAE attack, including anxiety, surgery, infection, and dental procedures. However, triggers vary from person to person, and attacks can be unpredictable.

In a clinical study, pediatric patients treated with Haegarda saw at least a 50% reduction in the number of HAE attacks experienced per month compared to the pre-study period. Recommended dosing is 60 International Units per kilogram of patient’s body weight administered every three or four days via subcutaneous injection. Haegarda can be administered at home by the patient or a caregiver who has been trained in proper administration technique by a healthcare provider.

Haegarda was first FDA approved in 2017.