Lilly receives recommendation for EU Bydureon approval

Lilly has been granted a recommendation from a European Medicines Agency committee for the approval of the developmental diabetes drug Bydureon.

The Committee for Medicinal Products for Human Use has issued a positive opinion on the exenatide-based treatment's approval as a treatment for type 2 diabetes in combination with certain oral therapies, based on positive clinical trial data.

Bydureon is the proposed trade name for the new compound, a glucagon-like peptide-1 receptor (GLP-1) agonist developed by Lilly in conjunction with Amylin Pharmaceuticals and Alkermes.

The CHMP ruling will now be considered by the European Commission, which will issue a final decision on the drug's approval within two to three months.

Enrique Conterno, president of Lilly's diabetes division, said: "If approved, Bydureon will offer patients the benefits of a GLP-1 receptor agonist in a once-weekly injection."

Earlier this year, the company announced a major new alliance with Boehringer Ingelheim that will see the firms collaborate on diabetes drug development.