FDA Approves Once-Monthly Hereditary Angioedema Drug

FDA 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...

FDA green lights CSL's once-monthly HAE drug Andembry

CSL has won FDA approval for Andembry, its once-monthly subcutaneous drug to prevent hereditary angioedema (HAE) attacks

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…

Garadacimab Shuts Down Contact Pathway to Treat HAE: Timothy Craig, DO

With the approval of the FDA, garadacimab can help patients with hereditary angioedema (HAE) prevent attacks by shutting down the contact pathway.

FDA approves CSL’s prophylactic for severe swelling condition

CSL Behring won FDA approval on Monday for its once-monthly preventive treatment for a rare, genetic condition that causes swelling episodes. Andembry is approved to prevent attacks of hereditary angioedema, also ...

Health Check: In shunning the IPO hot money, Tetratherix says ‘less is more’

Wound management house Tetratherix takes a haircut on its pending IPO, so the register has stayers rather than short-term players The FDA has approved CSL’s next-gen treatment for hereditary angioedema Nothing fishy as zebrafish don The Big Freeze beanies Wound management house Tetratherix is on track to list on Monday week, June 30, having shaved its initial public offer to $25 million from the targeted $35 million. Tetratherix’s EOFY special w…