Drugs
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Certolizumab pegol (Cimzia(®)) is a polyethylene glycolylated antigen-binding fragment of a recombinant human monoclonal antibody that binds to and selectively neutralizes tumour necrosis factor (TNF) α. In the EU, subcutaneous certolizumab pegol is indicated for the treatment of adults with severe active axial spondyloarthritis (axSpA), comprising ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA), and for adults with active psoriatic arthritis (PsA). In the USA it is indicated for the treatment of adults with active AS or active PsA. ⋯ In addition, 12 weeks' treatment with certolizumab pegol reduced inflammation in the sacroiliac joints and spine in patients with axSpA and 24 weeks' treatment with the agent slowed radiographic disease progression in patients with PsA. Certolizumab pegol was generally well tolerated in these studies, with a tolerability profile consistent with that seen in previous clinical trials in other indications. Although additional long-term and comparative data are needed to position certolizumab pegol with respect to other TNFα antagonists, current evidence indicates that certolizumab pegol is an effective option for the treatment of axSpA (including AS and nr-axSpA) and PsA.
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Ramucirumab (Cyramza™ [US]), a fully human immunoglobulin G1 (IgG1) monoclonal antibody that inhibits vascular endothelial growth factor receptor-2 (VEGFR-2), has been developed by Eli Lilly (formerly ImClone Systems) for the treatment of cancer. Ramucirumab has received its first global approval in the US for use as monotherapy in the treatment of advanced or metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma in patients who experience disease progression on or after fluoropyrimidine- or platinum-containing chemotherapy. Ramucirumab is the first treatment to be approved by the US FDA for this setting. This article summarizes the milestones in the development of ramucirumab leading to this first approval for the treatment of gastric cancer and gastro-oesophageal junction adenocarcinoma.
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Delamanid, a nitro-dihydro-imidazooxazole derivative, has been developed by Otsuka Pharmaceutical for the treatment of multidrug-resistant tuberculosis (MDR-TB). Delamanid received its first global approval for the treatment of MDR-TB in the European Union (EU), for use in combination with optimised background therapy. ⋯ Delamanid has been granted orphan drug status in both the EU and Japan. This article summarizes the milestones in the development of delamanid leading to this first approval for MDR-TB.