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.
Cablivi (caplacizumab) approved in Europe for adults with acquired
Press Release, source: Sanofi (euronext: SAN) (nyse: SNY). The approval of Cablivi provides an important addition to managing Multiple Sclerosis the standard of care treatment for patients with aTTP in Europe because it can significantly reduce time to platelet count normalisation and induce a clinically meaningful reduction in recurrences. Marie Scully, marie Scully, professor of haematology at University College London Hospitals, said: aTTP is a devastating disease. "aTTP is a devastating disease. The European Commission has authorised Cablivi (caplacizumab) as the first therapeutic specifically indicated for the treatment of adults affected by aTTP. We are excited about the opportunities to continue to expand our rare blood disorders business and to help many people with very serious diseases." aTTP Clinical Program and Results, the approval of Cablivi in the. Treatment for...
The prescribing information for Cablivi includes a warning to advise health care providers and patients about the risk of severe bleeding. The target action date for the FDA decision is February 6, 2019. Cablivi was developed by Ablynx, a Sanofi company. Importantly, treatment with caplacizumab resulted in a clinically meaningful reduction in the use of PEX and length of stay in the intensive care unit (ICU) and the hospital, compared to the placebo group.