Sanofi's Cablivi gains EU approval, Priority Review in U.S.

Sanofi (Euronext:SAN; NYSE:SNY) said the European Commission approved Cablivi caplacizumab to treat rare blood clotting disorder acquired thrombotic thrombocytopenic purpura (aTTP). The company also revealed Monday that FDA accepted and granted Priority Review to its BLA for the drug; the PDUFA date is Feb. 6, 2019.

Sanofi said Cablivi is the first approved drug for aTTP. The therapy was a key component of Sanofi's acquisition of Ablynx N.V. this year for about €3.9 billion ($4.8 billion). Ablynx remains a Sanofi subsidiary (see "Road to Acquisition")...