Drugs
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Idarucizumab (Praxbind(®)) is a fully humanized, monoclonal antibody fragment developed by Boehringer Ingelheim as a specific antidote to reverse the anticoagulant effect of the direct oral thrombin inhibitor dabigatran etexilate (Pradaxa(®)). Idarucizumab received its first global approval, in the USA, in October 2015 for use in adult patients treated with dabigatran etexilate when rapid reversal of its anticoagulant effects is required for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. Regulatory applications have been submitted in Canada and in the EU, where it has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use. This article summarizes the milestones in the development of idarucizumab leading to this first approval for reversing the anticoagulant effects of dabigatran in adults.
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Mepolizumab (Nucala(®)) is a fully humanized monoclonal antibody against interleukin-5 (IL-5) that is being developed by GlaxoSmithKline. Subcutaneous mepolizumab is approved in the USA for the add-on maintenance treatment of patients aged ≥12 years with severe asthma and an eosinophilic phenotype, and is awaiting approval in the EU. ⋯ In the phase III SIRIUS trial, mepolizumab had an oral glucocorticoid-sparing effect in patients with severe eosinophilic asthma requiring systemic glucocorticoid maintenance therapy. This article summarizes the milestones in the development of mepolizumab leading to this first approval for severe asthma with an eosinophilic phenotype.