Bydureon exenatide once weekly regulatory update

The U.K.'s NICE issued a final appraisal determination (FAD) recommending the use of once-weekly Bydureon exenatide to treat Type II diabetes in triple and dual therapy regimens. The FAD is in line with a preliminary appraisal issued last October (see BioCentury, Oct. 24, 2011). Final guidance is expected next month.

Bydureon is recommended in dual therapy (in combination with metformin or a sulphonylurea), if the patient is intolerant to either metformin or a sulphonylurea, or treatment with either is contraindicated and the person is intolerant of thiazolidinediones and dipeptidyl peptidase-4 (DPP-4) inhibitors, or treatment with the combination is contraindicated. Treatment in triple therapy (in combination with metformin and a sulfonylurea or thiazolidinedione) and dual therapy should only be continued if a beneficial response has been shown. ...