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GlaxoSmithKline's diabetes therapy Eperzan garners EU approval
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GlaxoSmithKline's diabetes therapy Eperzan garners EU approval (Ref: The Wall Street Journal, StockMarketWire, Yahoo!News, GlaxoSmithKline) March 26th, 2014 By: Joe Barber Tags: Top Story Eperzan GSK European Commission Diabetes General Practice Internal Medicine Marketing & Sales Regulatory Affairs The European Commission approved GlaxoSmithKline's GLP-1 receptor agonist Eperzan (albiglutide) for the treatment of type 2 diabetes mellitus in adults, the company reported Wednesday. The drugmaker said it plans to launch the once-weekly therapy in several European countries in the second half of 2014, with additional launches planned for later dates. Specifically, Eperzan is indicated to improve glucose control as a monotherapy, when diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to contraindications or intolerance. In addition, the drug is indicated to improve glucose control as add-on combination therapy, in combination with other glucose-lowering medicinal products, including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. GlaxoSmithKline noted that the approval was supported by the results of the Harmony clinical trial programme, which consisted of eight Phase III studies and included more than 5000 patients. The trials evaluated Eperzan against commonly-used classes of type 2 diabetes treatment, including insulin, in patients at different stages of the disease, as well as those with renal impairment. Data released last year showed that Eperzan met the primary goal of change from baseline in HbA1c versus placebo or active comparators in five studies. The drugmaker said that although many diabetes registration trials are six months in duration, patients were followed up for up to three years in five of the Harmony studies. The approval of Eperzan follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in January. Meanwhile, the FDA is expected to issue a decision on the therapy by April 15 after extending its review of the drug by three months to assess information requested from GlaxoSmithKline. For further analysis of the GLP-1 agonist market, read Physician Views Poll Results: Devices will play a key role in evolution of GLP-1 market, say endocrinologists, while for more information on the diabetes sector, see Diabetes: Battle for ascendancy escalates in expanding market - KOL Insight and Consensus Outlook Modules. http://www.firstwordpharma.com/node/1198431#axzz2x8bA0Z3V |
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