FDA grants breakthrough therapy designation to efanesoctocog alfa for hemophilia A

The FDA granted breakthrough therapy designation to efanesoctocog alfa for treatment of hemophilia A.
Efanesoctocog alfa (BIVV001; Sanofi, Sobi) is an investigational recombinant factor VIII therapy designed to extend protection from bleeds with once-weekly prophylactic dosing.
The FDA based the designation on results of the phase 3 XTEND-1 study.
Topline results showed the study met its primary endpoint, with efanesoctocog alfa resulting in a clinically meaningful prevention of bleeds among people with severe hemophilia A over a 52-week period, according to a Sanofi-issued press release.
The

The FDA granted breakthrough therapy designation to efanesoctocog alfa for treatment of hemophilia A.
Efanesoctocog alfa (BIVV001; Sanofi, Sobi) is an investigational recombinant factor VIII therapy designed to extend protection from bleeds with once-weekly prophylactic dosing.
The FDA based the designation on results of the phase 3 XTEND-1 study.
Topline results showed the study met its primary endpoint, with efanesoctocog alfa resulting in a clinically meaningful prevention of bleeds among people with severe hemophilia A over a 52-week period, according to a Sanofi-issued press release.
The