FDA Approves CSL’s Andembry, Directly Competing With Takeda’s Takhzyro in HAE

On June 16-17, 2025, the FDA approved CSL's Andembry (garadacimab-gxii) as a prophylactic treatment to prevent hereditary angioedema (HAE) attacks in patients aged 12 years and older12345.

Andembry is a first-in-class monoclonal antibody that selectively inhibits factor XIIa, providing a novel mechanism of action versus other HAE treatments, including Takeda's Takhzyro35.

The drug is administered as a once-monthly, subcutaneous self-injection delivered in 15 seconds or less using a citrate-free autoinjector, offering a convenient dosing option for patients45.

In the pivotal VANGUARD phase 3 trial, Andembry reduced HAE attacks by a median of more than 99% and a least squares mean of 89.2% compared to placebo5.

Andembry is the only prophylactic HAE therapy targeting the top of the disease cascade (factor XIIa) and is approved for all patients (adults and children 12+) from the start5.

CSL's Andembry is set to challenge Takeda's Takhzyro, the current market leader in HAE prophylaxis, by offering a differentiated mechanism of action and dosing convenience35.

Sources:

1. https://www.contemporarypediatrics.com/view/fda-approves-garadacimab-gxii-to-prevent-hae-attacks-in-patients-aged-12-years-older

2. https://www.pharmacytimes.com/view/garadacimab-gxii-receives-fda-approval-for-hereditary-angioedema-treatment

3. https://www.ajmc.com/view/fda-approves-garadacimab-in-hereditary-angioedema

4. https://pharmaphorum.com/news/fda-green-lights-csls-once-monthly-hae-drug-andembry

5. https://www.prnewswire.com/news-releases/us-food-and-drug-administration-approves-csls-andembry-garadacimab-gxii-the-only-prophylactic-hereditary-angioedema-hae-treatment-targeting-factor-xiia-with-once-monthly-dosing-for-all-patients-from-the-start-302483058.html