CSL's garadacimab meets Phase III goal for HAE

Results from the Phase III VANGUARD study evaluating garadacimab (CSL312) as a once-monthly, prophylactic treatment for attacks due to hereditary angioedema (HAE) met its primary and secondary endpoints, demonstrating that monthly subcutaneous injections of garadacimab significantly reduced the attack rate compared to placebo.

The findings have now been published in the prestigious journal The Lancet, said Australian biotech CSL Limited (ASX: CSL), which is developing the drug. With garadacimab, CSL is hoping to tap into a global market for HAE treatments which is currently estimated to be worth over $2.4 billion and is set to double in value by the next decade.

If approved, the product will go up against Takhzyro (lanadelumab), a hotly-tipped antibody sold by Japanese pharma giant Takeda (TYO: 4502), which is already on track to achieve blockbuster status.