AstraZeneca (NYSE:AZN) said today that the FDA approved its extended-release formulation of exenatide, Bydureon, for use as an add-on therapy to basal insulin in adults with Type II diabetes.
The company’s once-weekly GLP-1 injectable was first approved in the U.S. in 2012.
Bydureon’s expanded use is based on data from AstraZeneca’s 28-week Duration-7 trial, the company explained. Participants treated with Bydureon experienced a mean HbA1c reduction of 0.9% compared to just 0.2% in the placebo group.
The pharmaceutical company also reported that 32.5% of patients in the Bydureon group reached an HbA1c of less than 7% compared to 7% of patients in the placebo group.
The Duration-7 trial did not reveal any new safety findings, AstraZeneca added – the overall rate of hypoglycemia was comparable between both groups.
“Type II diabetes is a complex disease for patients and healthcare providers to manage, which is why we continue to invest in the advancement of science supporting the safety and efficacy of exenatide, even 13 years after the first exenatide formulation was introduced to the market,” Jim McDermott, VP of U.S. medical affairs for AstraZeneca’s diabetes business, said in prepared remarks.
“The Bydureon clinical program is one of the most extensive clinical trial programs of a GLP-1RA to date, having been studied in more than 19,000 patients. With this approval, we are providing another important treatment option for health care providers to consider for patients with type 2 diabetes on basal insulin with inadequate glycemic control,” he added.
Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.