Sanofi said the European Commission approved its drug Cablivi for treating acquired thrombotic thrombocytopenic purpura, or aTTP, a rare blood clotting disorder.
The disease causes extensive clots in a patient's small blood vessels, causing low platelet count, loss of red blood cells, restricted blood supply and organ damage. Cablivi was developed by Ablynx NV — a company Sanofi acquired in January.
The marketing authorization is based on a phase 3 study called Hercules and a phase 2 study called Titan. The EU regulator's nod follows a recommendation by the European Medicines Agency in June to approve the therapy.
Sanofi Genzyme, the Paris-based company's specialty care business unit, will work with authorities to make Cablivi available to patients across Europe.
Meanwhile, the U.S. Food and Drug Administration also granted priority review to Cablivi for treating patients 18 years and older experiencing an episode of aTTP. The U.S. regulator is expected to make a decision by Feb. 6, 2019.