WASHINGTON -- Caplacizumab (Cablivi), an antibody drug targeting von Willebrand factor, is now approved for acquired thrombotic thrombocytopenic purpura (aTTP), the FDA said Wednesday.
The drug is to be given in combination with plasma exchange and immunosuppressive treatment, the agency said, and is the first product approved specifically for aTTP. Made by Sanofi's Ablynx unit, caplacizumab was approved in Europe last September.
Acquired TTP develops as a consequence of other conditions including HIV infection, pregnancy, systemic lupus erythematosus, infections, or malignancies. It can also be secondary to surgery, bone marrow transplantation, or cancer chemotherapy, the FDA explained. The condition is marked by severe platelet deficiency and thrombotic events.
Approval was based primarily on a 145-patient randomized trial, in which patients receiving caplacizumab showed significantly faster recovery in platelet counts than those assigned to placebo. The drug was also associated with fewer aTTP-related deaths and treatment-emergent thrombotic events. Recurrence of aTTP during treatment plus a 4-week follow-up period was 13% with caplacizumab versus 38% with placebo, the FDA said.
"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 Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, in a statement announcing the approval. "Cablivi is the first targeted treatment that inhibits the formation of blood clots. It provides a new treatment option for patients that may reduce recurrences."
Common adverse effects seen with the drug include headache and bleeding from the nose or gums.
Acquired TTP Drug Wins Approval - HCP Feed
Cablivi is the first targeted treatment that inhibits the formation of blood clots. The current available treatments include plasma exchange and education May Not Protect Against Dementia immunosuppression. The disease affects fewer than 2000 adult patients annually. The drug is to be given in combination with plasma exchange and immunosuppressive treatment, the agency said, and is the first product approved specifically for are ORs Really Clean? General Surgery News Report aTTP. About drugs simply
If after the initial treatment course, signs of persistent underlying disease such as suppressed adamts13 activity levels remained present, treatment was extended for 7-day intervals for a maximum of 28 days. The most common adverse reactions in at least 15 of patients receiving caplacizumab-yhdp were epistaxis, headache, and gingival bleeding. Published February 6, 2019. There have been limited medicines available to treat aTTP until now says Olivier Brandicourt, MD, chief executive officer of Sanofi, the manufacturer of the caplacizumab-yhdp. The results of the trial demonstrated that platelet counts improved faster among patients treated with Cablivi, compared to placebo.
Washington Caplacizumab (Cablivi an antibody drug targeting von Willebrand factor, is now approved for acquired thrombotic thrombocytopenic purpura (aTTP the FDA said Wednesday. The drug is to be given in combination with plasma exchange and immunosuppressive treatment, the agency said, and is the first product approved specifically for aTTP. Acquired TTP Drug Wins Approval. 17:45 via m - medical news plus CME for physicians. Anti-anginal agent short-term health insurance in Colorado: find affordable coverage is the latest drug to flop as an effective therapy remains elusive Read more. Classification System Ties Cardiac Changes to Post-tavr Outcome. Sanofi blood disorder drug wins, fDA approval.Reply
Called acquired thrombotic thrombocytopenic purpura (aTTP is a idaho and the ACA’s Medicaid expansion: eligibility, enrollment and benefits life-threatening, autoimmune disorder characterized by clot formation. The treatment, called Cablivi, is already approved in the European Union as a treatment for acquired forms of the disorder, called thrombotic thrombocytopenic purpura. Caplacizumab-yhdp, approved by FDA For, acquired Thrombotic Thrombocytopenic Purpura. Targeted Therapies End the Dry Spell in AML. Drug, development Duvelisib Effective After Progression on Ofatumumab in CLL. February 6, 2019 - The.S.Reply
Drug, administration today approved, cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in short-term health insurance in the District of Columbia: find affordable coverage combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP a rare and life-threatening disorder that causes blood clotting. Cablivi is the first.S. Approval for Sanofis new rare blood disorders franchise paris February 6, 2019 The.S. Drug, administration (FDA) has approved, cablivi (caplacizumab-yhdp) in combination with plasma exchange and immunosuppression for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP) in adults. Cablivi is the first FDA approved therapy specifically indicated for the treatment of aTTP. February 6, 2019 The.S. Food and Drug Administration today approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP a rare and life-threatening disorder that causes blood clotting.Reply
FDA Approves Caplacizumab-yhdp for Acquired Thrombotic Thrombocytopenic Purpura February 6, 2019 On February 6, 2019, the Food and Drug Administration approved caplacizumab-yhdp (cablivi, Ablynx NV) for adult patients with acquired thrombotic thrombocytopenic purpura (aTTP in combination with plasma exchange and immunosuppressive therapy). Managing chronic pain doesnt mean relying only on opioid prescription pain relievers or over-the-counter pain medications. Proper research prior to usage is always recommended. Literally everything you dC health insurance marketplace: history and news of the state’s exchange: Obamacare enrollment ever need to know about using the ketogenic diet for weight loss so you can fit into your favorite clothes again. The nhtsa study also found that analyzing a drivers. Plastics contain toxic chemicals, which can increase risk of disease.Reply
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