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 Sept. 3 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")...