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 little Evidence Pain Creams Work adults with
Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application for caplacizumab for treatment of aHA News: Post-Stroke Depression Common Among Black, Hispanic Survivors patients 18 years of why Do More and More Americans Use Medical Marijuana? age and older experiencing an episode of aTTP. From the Bioverativ acquisition, Sanofi got hemophilia drugs Eloctate and Alprolix. The company contends that nanobodies have several advantages over other molecules and are ideal building blocks for novel biologics. The drug has been approved based on data from the phase II titan and phase III hercules studies in 220 adults. No deaths were reported during study drug treatment in the caplacizumab group in the titan and hercules studies, while for the placebo group, two deaths were reported in the titan study and three deaths in the hercules study. For the second quarter, Eloctate turned in sales of 176 million, up 20 at constant exchange rates, while Alprolixs 81 million represented.6 growth. About drugs simply
Cablivi, Ablynx adds to Sanofi a deep pipeline, including an inhalable drug that treats RSV in infants. "aTTP is a devastating disease. PRNewswire / - (euronext: SAN) (nyse: SNY) - The European Commission has granted marketing authorization for Cablivi (caplacizumab) for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP a rare blood-clotting disorder. The existing treatment of daily plasma exchange (PEX) and immunosuppression is still associated with aTTP episodes linked to a mortality rate of up to 20, with most deaths occurring within the first month of diagnosis. Many patients undergoing current standard of care treatment continue to be at risk of developing acute thrombotic complications, including stroke and heart attack, recurrence of the disease, lack of treatment response and death.
Cablivi is the first approved therapy specifically indicated for aTTP, a rare and life-threatening disorder that aHA News: High Blood Pressure Top Risk Factor for Stroke in Young Adults causes patients to develop blood clots throughout the body. Cablivi is the company s first Nanobody -based medicine to receive approval and the first newly approved product that will be part of Sanofi Genzyme. Rare, blood, disorders franchise. Earlier this year, Sanofi acquired Bioverativ which has treatments for hemophilia A and. Officials with the FDA have approved caplacizumab-yhdp cablivi, Sanofi) injection for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP a rare and life-threatening blood clotting autoimmune disorder. The European Commission has approved, sanofis, cablivi, the first treatment for patients with the rare blood- clotting disorder, acquired thrombotic thrombocytopenic purpura (aTTP which is also.Reply
Sanofi s nanobody drug. Cablivi, acquired from its buyout of Ablynx, has been approved in Europe for a rare blood- clotting disorder. First medicine approved in the.S. Specifically for the treatment of aTTP, a rare blood- clotting disorder, cablivi is the first.S. Approval for Sanofi s new rare blood disorders franchise.Reply
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