(Reuters) – The U.S. Food and Drug Administration (FDA) said on Wednesday it had approved Sanofi SA’s drug to treat a rare blood-clotting disorder in adults in combination with standard-of-care treatments.

The treatment, called Cablivi, is already approved in the European Union as a treatment for acquired forms of the disorder, called thrombotic thrombocytopenic purpura.

Cablivi should come with a warning about the risk of severe bleeding, the FDA said.