Posted by Michael Wonder on 15 Dec 2023
CSL's garadacimab, a first in class factor XIIa inhibitor, receives FDA and EMA filing acceptance
14 December 2023 - These regulatory milestones bring CSL one step closer to delivering on our promise to patients with a first in class recombinant monoclonal antibody for people living with HAE, a community CSL has been serving for over 40 years, in the US and European Union.
CSL today announced the US FDA has accepted the company's biologics license application for garadacimab (CSL312) as a once-monthly prophylactic treatment for hereditary angioedema.
