Sanofi earns breakthrough nod in hemophilia A as it continues to play catch-up with Roche's Hemlibra
As Sanofi prepares to present its hemophilia A pitch to the FDA, regulators are acknowledging the potential of the Big Pharma’s experimental drug.
The agency granted breakthrough therapy designation to Sanofi’s factor VIII replacement therapy efanesoctocog alfa early Wednesday morning, roughly three months after the program read out positive Phase III data. It’s a boost for Sanofi and partner Sobi, who are trying to beat several gene therapies to market and take on Roche’s Hemlibra, among other prominent drugs from Bayer, Takeda and Novo Nordisk.
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