EU Approves Albiglutide for Type 2 Diabetes

EU Approves Albiglutide for Type 2 Diabetes

GlaxoSmithKline LogoOn March 27, 2014, the EU announced their approval of Albiglutide for patients diagnosed with Type 2 Diabetes. This approval was expected by GlaxoSmithKline, as Albiglutide, known as their brand name drug Eperzan, received a positive opinion from the EU at the commencement of 2014. The unique ability of Albiglutide to act as an effectual monotherapy anti-diabetic treatment makes this GLP-1 receptor agonist ideal for many patients. A sizable patient population with Type 2 Diabetes are unable to take certain first line treatments alongside Metformin, which is a typical, add on drug. This group of patients who are unable to tolerate Metformin have proven to benefit greatly from Albiglutide as their only source of glucose regulation. The EU has officially approved Albiglutide for monotherapy in patients who have not found adequate control of their glucose levels through diet and exercise, and who cannot tolerate Metformin. Albiglutide has also been approved as an add-on medication to be used in combination with other glucose-lowering treatments, such as basal insulin for patients who need additional glycemic control.

European Medicines AgencyOffered as a prefilled injectable pen, Albiglutide comes in either 30 milligram or 50 milligram doses. The use of a prefilled pen makes it easy for patients to not only administer their dose, but also to adhere to a regular schedule of just one medication to treat their Type 2 Diabetes. Roughly 5000 patients were enrolled in eight phase 3 trails, which gleaned positive results. The vast majority of patients in these trials were evaluated for almost three years’ time, and trial goals were met in five of the trials. These results are extremely encouraging as almost fifty percent of patients with Type 2 Diabetes fail to adequately control their glucose levels on a regular basis. Albiglutide has a U.S. Prescription Drug User Fee Act (PDUFA) target date of April 15th by the FDA.

LGM Pharma provides Albiglutide CAS# 782500-75-8, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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