GlaxoSmithKline: Albiglutude ‘superior’ to placebo in Harmony Outcomes study

GSK and the Duke Clinical Research Institute announced publication of results from the Harmony Outcomes study which assessed the cardiovascular safety and efficacy of albiglutide, a GLP-1 receptor agonist, in patients with type 2 diabetes and cardiovascular disease. Results were presented at the European Association for the Study of Diabetes congress 2018 with simultaneous publication in The Lancet. The study was initiated in July 2015 and GSK remained committed to completing it following an announcement in July 2017 of GSK’s intention to cease further R&D, manufacturing and sales activity for albiglutide. Prior studies of GLP-1 receptor agonists when used in patients with diabetes and CV disease had provided inconsistent results regarding the potential benefit, and GSK believed that the data generated from this study could contribute important new evidence to the field. The primary outcome showed that albiglutide, administered subcutaneously once-weekly in 9463 patients over a median period of 1.6 years, was superior to placebo in reducing the risk of major adverse cardiovascular events by 22% when used in addition to standard of care in patients with type 2 diabetes and cardiovascular disease. Dr John Lepore, Senior Vice President R&D Pipeline, GSK said: “Harmony Outcomes was an important study for us to complete to generate new data and insights about the role of the GLP-1 receptor agonist class in the management of patients with diabetes and cardiovascular disease. GSK continued to invest in this study following a decision last year to cease all other activities on albiglutide, and we continue to explore opportunities to divest this medicine to a company with the right expertise and resources to realise its full potential for patients.”
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