Ablynx NV`s Cablivi (caplacizumab) Receives Suppl Approval in the U.S.
Cablivi's Biologic Ablynx (Caplacizumab) Receives Approval in the U.S.
The UK’s National Institute for Health and Care Excellence (NICE) has given a green light to Sanofi’s Cablivi for acquired thrombotic thrombocytopenic purpura (aTTP) – a rare and potentially life-threatening blood clotting disorder.
NICE has drawn up draft guidelines rejecting Sanofi's Cablivi (caplacizumab) for use alongside plasma exchange and immunosuppression for treating an acute episode of acquired thrombotic thrombocytopenic purpura (TTP).
Cablivi® is the first treatment approved in Canada for aTTP, a life-threatening blood clotting disordernIt's estimated that up to 20% of patients die from TTP episodes, despite currently available treatments1,2
The Centers for Medicare & Medicaid Services (CMS) recently published its 2020 final Inpatient Prospective Payment System (IPPS) rule, awarding Cablivi (caplacizumab-yhdp) the New Technology Add-on Payment (NTAP) status.
Immunovant has named Robert Zeldin as its chief medical officer. Zeldin, who last worked as CMO of Acceleron Pharma, arrives at Immunovant shortly after it moved its lead drug into phase 2 trials in two indications.
(Reuters) - The U.S. Food and Drug Administration (FDA) said on Wednesday it had approved Sanofi SA’s drug to treat a rare blood-clotting disorder in adults in combination with standard-of-care treatments.
Ablynx NV's Biological Cablivi (Caplacizumab-Yhdp) Receives Supplemental Approval in US
SILVER SPRING, Md., Feb. 6, 2019 /PRNewswire/ -- The U.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. Patients with aTTP develop extensive blood clots in the small blood vessels throughout the body. These clots can cut off oxygen and blood supply to the major organs and cause strokes and heart attacks that may lead to brain damage or death. Patients can develop aTTP because of conditions such as cancer, HIV, pregnancy, lupus or infections, or after having surgery, bone marrow transplantation or chemotherapy.