Cablivi Approved for Rare Clotting Disorder
WEDNESDAY, Feb. 6, 2019 -- Cablivi (caplacizumab-yhdp) injection has been approved by the U.S. Food and Drug Administration to treat adults with acquired thrombotic thrombocytopenic purpura (aTTP), a rare and deadly disorder that causes blood clotting.
"Patients with aTTP endure hours of treatment with daily plasma exchange, which requires being attached to a machine that takes blood out of the body and mixes it with donated plasma and then returns it to the body. Even after days or weeks of this treatment, as well as taking drugs that suppress the immune system, many patients will have a recurrence of aTTP," said Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence.
People with aTTP develop blood clots in the small blood vessels throughout the body. The clots can cut off oxygen and blood supply to the major organs and cause strokes and heart attacks, the agency said Wednesday in a news release. Patients with cancer, HIV, pregnancy, lupus or infections are at greater risk of developing the disorder.
Cablivi was evaluated in clinical studies involving 145 people. Those treated with Cablivi had fewer instances of aTTP-related death, the FDA said.
Common side effects include headache and bleeding of the nose or gums.
Cablivi's prescribing information includes a warning about the risk of severe bleeding. Health care providers should monitor closely people who also take blood-thinning medications, the FDA said.
The drug is produced by Ablynx, based in Belgium.
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Posted: February 2019