FDA nod for CSL’s Andembry adds to HAE treatment landscape

Australian biotech CSL (ASX:CSL) has announced that the US Food and Drug Administration (FDA) has approved Andembry (garadacimab-gxii), the only treatment targeting factor XIIa for prophylactic use to prevent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. 

By targeting factor XIIa, a plasma protein that plays a key role in attacks of swelling in people with HAE, Andembry inhibits the top of the HAE cascade to prevent HAE attacks. 

Andembry is the only treatment to offer once-monthly dosing from the start for all patients and is a subcutaneous self-injection delivered in 15 seconds or less via an autoinjector with a citrate-free formula.