CSL’s Garadacimab Receives FDA and EMA Filing Acceptance
CSL today announced the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for garadacimab (CSL312) as a once-monthly prophylactic treatment for hereditary angioedema (HAE). The company also announced the European Medicines Agency (EMA) has accepted the submission for CSL’s Marketing Authorization Application (MAA) for garadacimab. If approved, garadacimab would become the first treatment for HAE in the U.S. and EU to target activated Factor XII (FXIIa).
Garadacimab is a novel, first-in-class, recombinant monoclonal antibody targeting activated FXII. FXIIa is a plasma protein that initiates the kallikrein-kinin cascade of HAE attacks. By targeting FXIIa, garadacimab inhibits this cascade at the top as compared to HAE therapies that target downstream mediators.
Emmanuelle Lecomte Brisset, Pharm D, Senior Vice President and Global Head of Regulatory Affairs at CSL, said: “CSL is a company with a deep heritage in developing innovative treatments for the rare disease community, and we are extremely proud that our first homegrown recombinant monoclonal antibody is progressing our commitment to support HAE patients in need. We believe that garadacimab has the potential to become a promising therapy in the prevention of HAE attacks and we look forward to working closely with global health regulators throughout the review process.”
Orphan-drug designation for garadacimab as a therapy for hereditary angioedema has been granted by both the FDA and the EMA.
(Source: CSL)
