FDA Approves AstraZeneca's Bydureon Pen For Type 2 Diabetes
AstraZeneca announced that the US Food and Drug Administration (FDA) gave its approval for Bydureon Pen (exenatide extended-release for injectable suspension) 2 mg as an adjunct treatment to proper diet and exercise to improve blood sugar control in patients with type 2 diabetes.
Briggs Morrison, Executive Vice President of Global Medicines Development and Chief Medical Officer of AstraZeneca, said, “We’re pleased to receive approval for the BYDUREON Pen, which can provide a powerful reduction in blood glucose levels along with the potential benefit of weight loss, through a once-weekly dose in a pre-filled device. We are committed to addressing the needs of adults with type 2 diabetes, including ongoing research to develop new treatments and methods of delivery.”
Type II diabetes accounts for an estimated 90 to 95% of all cases of diagnosed diabetes, which affects approximately 25.8 million people in the US alone and over 382 million worldwide. Type II diabetes is a chronic disease defined by pathophysiologic defects causing elevated glucose levels.
Bydureon Pen delivers exenatide via microsphere technology in a once-weekly dose with no titration requirement. The product can be administered any time of the day with or without meals. The drug has demonstrated potent HbA1c (blood glucose level) reduction.
The FDA approval for Bydureon was granted in 2012 and was based on the safety and efficacy data from DURATION-5 clinical trial. The pivotal trial was a randomized open-label clinical study of 252 adult patients with type 2 diabetes and who had poor glycaemic control with diet and exercise alone or with oral antidiabetic therapy. This included metformin, a sulfonylurea, a thiazolidinedione or a combination of two of these comparing BYDUREON to BYETTA (n = 129 and n = 123, respectively). Patients taking once-weekly Bydureon experienced statistically significant mean reduction in HbA1c of 1.6 percentage points (8.5% baseline), compared to a reduction of 0.9 percentage points (8.4% baseline) for patients taking BYETTA.
The company announced plans to make Bydureon Pen available for patients in the US later in 2014.
Source: http://www.astrazeneca.com/Media/Press-releases/Article/03032014-us-fda-approves-bydureon-pen