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news.Eli Lilly, Amylin Pharmaceuticals and Alkermes have received the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency's (EMA) positive opinion for their injectable diabetes drug for the treatment of type 2 diabetes in combination with certain oral therapies.
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The companies’ exenatide 2 mg powder and solvent for prolonged release suspension for injection (proposed trade name Bydureon) has been recommended to be used as a once-weekly 2mg dose to improve glycemic control in adults who have not achieved adequate glycemic control on maximally tolerated doses of these oral therapies.
The CHMP’s positive opinion is a step forward towards getting European Commission’s approval for the companies’ type 2 diabetes drug.
According to the companies, the CHMP’s decision was based on the review of the submission package, including data from studies in the Duration clinical program in which exenatide resulted in improvements in glycemic control with just one dose per week.
Lilly Diabetes president Enrique Conterno said the CHMP’s positive opinion is a pivotal step toward marketing authorization for Bydureon in Europe.
"If approved, Bydureon will offer patients the benefits of a GLP-1 receptor agonist in a once-weekly injection," Conterno said.