Australia-based global biotechnology company CSL (ASX:CSL) announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended marketing authorization for garadacimab, a monoclonal antibody for hereditary angioedema (HAE) prophylaxis in patients aged 12 and older.

Garadacimab targets activated factor XII to prevent HAE attacks by inhibiting the cascade at its origin. The European Commission's final decision is anticipated in Q1 2025.

The CHMP opinion is supported by data from the Phase 3 VANGUARD trial and its open-label extension, showing garadacimab reduced the mean number of monthly HAE attacks by 86.5% and sustained attack-free status in 62% of patients. Long-term safety and efficacy were confirmed in ongoing studies, with results published in The Lancet and Allergy.

If approved, garadacimab's marketing authorization would apply across all EU member states. HAE, a rare genetic condition affecting 1 in 10,000–50,000 individuals, causes severe swelling and can lead to life-threatening complications, including airway obstruction. Existing therapies act downstream in the HAE cascade, while garadacimab addresses it at its source.