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

Core Viewpoint - CSL has received FDA approval for ANDEMBRY®, a novel treatment for hereditary angioedema (HAE), marking a significant advancement in the management of this rare genetic disorder [1][3][11] Group 1: Product Overview - ANDEMBRY is the first monoclonal antibody developed entirely by CSL, targeting factor XIIa to prevent HAE attacks in patients aged 12 and older [1][3][11] - The treatment offers once-monthly subcutaneous self-injection, providing a convenient administration method [1][3] - ANDEMBRY has shown a median reduction of more than 99% in HAE attacks compared to placebo, with a least squares mean reduction of 89.2% [6][7] Group 2: Clinical Trial Data - The approval is based on data from the pivotal Phase 3 VANGUARD trial, which demonstrated the efficacy and safety of ANDEMBRY [3][12] - In the pivotal trial, 62% of patients treated with ANDEMBRY remained attack-free throughout the treatment period [7] - The most common adverse reactions reported were nasopharyngitis and abdominal pain, with injection-site reactions occurring in 14% of patients [4][7] Group 3: Market Impact and Availability - ANDEMBRY's approval expands CSL's HAE franchise and reinforces the company's commitment to innovation in the HAE community [6][8] - The product is set to launch commercially immediately, with availability expected before the end of June 2025 [9] - ANDEMBRY has also received approvals in multiple regions, including Australia, the UK, the EU, Japan, Switzerland, and the UAE [8]