SAN Sanofi

(Adds novelty of the treatment, price in Germany and price for existing treatment in the U.S.)

--FDA approves a treatment from Sanofi subsidiary Ablynx for a rare blood disease

--Cablivi is the first nanobody-based drug that has been approved in the EU as a novel therapeutic platform, Sanofi said.

--Cablivi has been designated an orphan drug, which makes it eligible for incentives to encourage development of drugs for rare diseases

 
   By Stephen Nakrosis and Donato Paolo Mancini 
 

The U.S. Food and Drug Administration has approved a treatment for a rare blood-clotting disorder to Ablynx, a subsidiary of Sanofi SA (SAN.FR).

The injections of Cablivi in combination with plasma exchange and immunosuppressive therapy comprise 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 is the first nanobody-based drug that has been approved in the EU as a novel therapeutic platform, said Rand Sutherland, global head of medical affairs at Sanofi Genzyme. Sanofi acquired Ablynx last year for $4.85 billion, having purchased the drug from it shortly before, he said.

Cablivi has been designated an orphan drug, which the FDA said provides incentives to assist and encourage the development of drugs for rare diseases.

The price for a full Cablivi treatment in Germany is EUR160,000 ($183,000). This is the only European market for which there is currently a price, a Sanofi spokeswoman said.

The U.S. list price, or wholesale acquisition cost, for treating a typical acquired thrombotic thrombocytopenic purpura episode with Cablivi is $270,000, Sanofi said Wednesday.

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

(END) Dow Jones Newswires

February 06, 2019 13:00 ET (18:00 GMT)

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