US EditionFDA Approves Once-Monthly Hereditary Angioedema Drug
- On June 16, 2025, the FDA approved ANDEMBRY by CSL for prophylactic use to prevent hereditary angioedema attacks in patients aged 12 and older in the US.
- This approval follows successful Phase 3 clinical trials showing ANDEMBRY's efficacy in blocking activated factor XIIa, a protein that triggers swelling in HAE patients.
- ANDEMBRY is a once-monthly subcutaneous injection that reduced attacks by over 99 percent median compared to placebo and had 62 percent of treated patients attack-free during six months of study.
- Dr. Tim Craig noted that existing treatments require frequent injections, while CSL’s head of R&D said ANDEMBRY offers long-term control with convenient dosing and a favorable safety profile.
- CSL will launch ANDEMBRY commercially immediately, expanding options for the rare genetic disorder affecting about 1 in 10,000 to 1 in 50,000 people and improving prophylaxis availability.
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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…
FDA Approves ANDEMBRY® for Preventing Hereditary Angioedema Attacks
KING OF PRUSSIA, PA — The U.S. Food and Drug Administration (FDA) has approved ANDEMBRY® (garadacimab-gxii), developed by CSL, as the first treatment targeting factor XIIa for the prevention of hereditary angioedema (HAE) attacks. This milestone marks a significant advancement in managing the rare, chronic, and potentially life-threatening condition, offering patients a more convenient and effective treatment option. ANDEMBRY is the only prophyl…
FDA Approves New Preventive Drug for Hereditary Angioedema (HAE)
People with hereditary angioedema (HAE) , a rare genetic disorder, may experience episodes of debilitating, unpredictable, and potentially life-threatening swelling in the abdomen, larynx (voice box), face, and extremities. But there is a new, first-of-its-kind drug to prevent these attacks: The U.S. Food and Drug Administration (FDA) has approved Andembry (garadacimab), a once-monthly medicine injected under the skin, for adults and children 12…
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