Physicians' Academy for Cardiovascular Education

EMA’s CHMP backs approval of albiglutide for type 2 diabetes

News - Jan. 27, 2014

The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of the diabetes drug albiglutide. This treatment might be a new option for people with uncontrolled type 2 diabetes for managing their condition.

The CHMP opinion relates to use of the once-weekly GLP-1 receptor agonist 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 decision covers use of albiglutide as add-on 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.
The CHMP's decision was based on data from eight Phase III trials involving more than 5000 patients.
In a number of other countries, marketing applications for albiglutide are also under consideration, with the FDA set to decide on approval of the drug by April 15 after extending its review in August last year.

Source: EMA Pending EC decisions

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