US EditionFDA Approves Once-Monthly Hereditary Angioedema Drug
UNITED STATES, JUN 18 – ANDEMBRY reduces hereditary angioedema attacks by over 99% median and offers convenient once-monthly injections for patients aged 12 and older, based on pivotal phase 3 trial data.
- The U.S. FDA approved ANDEMBRY on June 16, 2025, for preventing hereditary angioedema attacks in patients aged 12 and older in the United States.
- This approval follows a pivotal Phase 3 VANGUARD trial and prior market approvals in the EU, UK, Japan, Australia, and other regions, highlighting unmet needs in HAE treatment.
- ANDEMBRY is a novel once-monthly subcutaneous monoclonal antibody that inhibits activated factor XIIa, blocking a key step causing life-threatening swelling episodes in HAE patients.
- In the VANGUARD trial, treatment with ANDEMBRY led to a greater than 99 percent median decrease in HAE attacks compared to placebo, with nearly two-thirds of patients remaining free of attacks over a six-month period.
- CSL Behring plans immediate commercial launch of ANDEMBRY in the U.S., providing patients a long-acting preventive option with a favorable safety profile and potential to reduce treatment burden.
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128 Articles
MedPage Today
Anti-Aging, Acupuncture and Health NewsFDA Approves Once-Monthly Hereditary Angioedema Drug
(MedPage Today) -- Anti-factor XIIa biologic garadacimab (Andembry) got the FDA greenlight for use in preventing hereditary angioedema (HAE) attacks in adult and pediatric patients ages 12 years and older, CSL announced. Garadacimab is the only...
The Berkshire Eagle
U.S. Food and Drug Administration Approves CSL's ANDEMBRY® (garadacimab-gxii), the Only Prophylactic Hereditary Angioedema (HAE) Treatment Targeting Factor XIIa with Once-Monthly Dosing for All Patients From the Start
ANDEMBRY inhibits the top of the HAE cascade by targeting factor XIIa and provides sustained protection from attacksOnce-monthly dosing reduced HAE attacks by a median of more than 99 percent and a least squares mean of 89.2 percent, compared to…
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