EU Offers Positive Opinion for Type 2 Diabetes Drug Albiglutide

EU Offers Positive Opinion for Type 2 Diabetes Drug Albiglutide

CHMP logoThe EU has offered a positive opinion to GlaxoSmithKline for their type 2 diabetes drug Albiglutide, known as the brand name Eperzan. The unique once weekly dosage of this GLP-1 receptor agonist is only one of the reasons for a hopeful EU approval in the near future. Albiglutide is intended as a monotherapy for patients with type 2 diabetes, and an ideal treatment for patients who cannot tolerate the commonly prescribed metformin as an add-on therapy. The anticipated approval from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is expected by May 2014. A potential approval is also being awaited on in the United States, with an FDA decision expected by April 2014.

Albiglutide will be offered as a prefilled injectable pen with either 30 milligram or 50 milligram dosages. The easy use of the prefilled pen is expected to appeal to patients and increase the likelihood of medication adherence. Comprehensive and extensive clinical trials were completed regarding the use of Albiglutide in patients with type 2 diabetes. There was an astounding 5000 patients evaluated in 8 phase 3 trials. The patients involved included those recently diagnosed with type 2 diabetes, long term sufferers of the disease and participants with renal impairment. With the majority of patients in the studies being evaluated for up to three years, the goals were met in 5 of the total trials.  Research and development of drugs to fight the onslaught of type 2 diabetes cases worldwide is urgent. Recent projections for the growing European population with type 2 diabetes diagnoses have led analysts to project 15.46 billion dollars in profits by the year 2017 for the EU.

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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LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

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