The Chicago Entrepreneur

FDA gives Sanofi’s experimental hemophilia A drug a Breakthrough Therapy designation

Sanofi said Wednesday that the Food and Drug Administration granted a Breakthrough Therapy designation to the hemophilia A treatment it’s developing with Swedish Orphan Biovitrum AB . The company said it plans to ask the FDA to approve efanesoctocog alfa this summer. The experimental therapy has previously been granted Orphan Drug status and has been given a Fast Track designation in the U.S. The U.S.-listed shares of Sanofi have gained 6.3% this year, while the broader S&P 500 is down 13.3%.

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