Sanofi dives deeper into phase 3 data for Hemlibra rival as FDA decision approaches

As an FDA approval decision looms, Sanofi has unveiled more data from a phase 3 trial of its potential hemophilia A rival to Roche’s blockbuster Hemlibra.

The French pharma first posted topline data from the trial last March, showing that efanesoctocog alfa hit the primary endpoints of inducing a low annualized bleed rate (ABR). Now, a deeper dive shows that once weekly dosing of the factor VIII (FVIII) therapy delivered normal to near-normal factor activity levels of more than 40% over the majority of the week.