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Gabapentin enacarbil is an extended-release prodrug of gabapentin that is approved in the USA (Horizant®) and Japan (Regnite®) for the treatment of moderate to severe primary restless legs syndrome (RLS) in adults [featured indication]. This article summarizes pharmacological, efficacy and tolerability data relevant to the use of oral gabapentin enacarbil in this indication. In double-blind, multicentre...
Reslizumab (Cinqair®) is a humanised monoclonal interleukin-5 (IL-5) antibody developed by Teva that has been approved in the USA for patients aged ≥18 years as add-on maintenance treatment for severe asthma with an eosinophilic phenotype. IL-5 stimulates the production, activation and maturation of eosinophils and is therefore thought to play a role in the development of bronchial hyper-responsiveness...
Eltrombopag (Promacta®; Revolade®) is an orally active thrombopoietin receptor agonist recently approved in the USA and the EU for use in paediatric patients aged ≥1 year with chronic immune thrombocytopenia (ITP) who have had an insufficient response or are refractory to other ITP treatments (e.g. corticosteroids, immunoglobulins or splenectomy). The efficacy of 7 or 13 weeks’ therapy with oral eltrombopag...
Azacitidine (Vidaza®) is a pyrimidine nucleoside analogue of cytidine and is approved in the EU for use in patients with higher-risk myelodysplastic syndromes (MDS) and acute myeloid leukaemia (AML), including older patients (aged ≥65 years) with AML with >30 % bone marrow blasts (BMB) who are ineligible for haematopoietic stem cell transplant. This article reviews the clinical efficacy and tolerability...
Secondary hyperparathyroidism (SHPT) is a common complication of chronic kidney disease (CKD) and is part of the CKD-mineral bone disorder (CKD-MBD). SHPT is associated with increased risk of fracture and mortality; thus, SHPT control is recommended as kidney function declines. Effective SHPT management becomes more difficult once skeletal and cardiovascular adverse effects associated with severe...
Monoclonal antibodies (mAbs) are a recent addition to multiple myeloma (MM) therapies and a number of mAbs directed at myeloma cell surface molecules are in development. Daratumumab is a CD38 mAb that has demonstrated substantial activity and good tolerability in four phase I, phase I/II and phase II studies as monotherapy, as well as in combination with current standard treatments in MM. The positive...
Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) represent the standard of care for advanced non-small cell lung cancer (NSCLC) patients whose tumor harbors an activating EGFR mutation. The vast majority of patients will experience disease control with an EGFR-TKI but inevitably all patients will progress, often within a year of treatment. There is no current standard of care...
Ixekizumab (Taltz®) is a humanised monoclonal immunoglobulin G antibody developed by Eli Lilly and Company that has been approved in the USA as a treatment for plaque psoriasis. Ixekizumab is a specific inhibitor of interleukin-17A (IL-17A), a pro-inflammatory cytokine that has a role in the development of several inflammatory conditions. This article summarizes the milestones in the development of...
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