By Stephen Nakrosis

The U.S. Food and Drug Administration on Wednesday said the gave approval for Cablivi, a treatment for a rare blood clotting disorder, to Ablynx, a subsidiary of Sanofi SA (SAN.FR).

Cablivi injections, in combination with plasma exchange and immunosuppressive therapy, is the first therapy specifically indicated to treat adult patients with acquired thrombotic thrombocytopenic purpura, a rare and life-threatening disorder that causes blood clotting.

Patients with the condition develop extensive blood clots in the small blood vessels throughout the body, the FDA said, which can cut off oxygen and blood supply to the major organs. Patients can develop acquired thrombotic thrombocytopenic purpura from a variety of conditions, including cancer, HIV, pregnancy, lupus or infections. The condition can also come about after having surgery, bone marrow transplantation or chemotherapy, the FDA said.

Cablivi also received orphan drug designation, which the agency said provides incentives to assist and encourage the development of drugs for rare diseases.

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

February 06, 2019 12:01 ET (17:01 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.
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