The approval marks the third time the FDA has considered Bydureon, which is manufactured by Alkermes PLC and Amylin Pharmaceuticals Inc. Previously the FDA had expressed concerns that it may increase the risk of heart problems. As part of the new approval, Bydureon manufacturers must now conduct a study to determine whether the drug does increase these risks.
The approval is based on results from a 24-week study that showed people who used the new drug had greater improvements in their blood sugar with just one dose per week, compared with people treated with Byetta injection. The most common side effects were nausea, diarrhea, headache, vomiting, constipation, itching at the injection site, a small bump at the injection site, and indigestion.
“With Bydureon, U.S. physicians and patients can now choose a therapy that offers continuous blood sugar control in just one dose per week,” says John Buse, MD, PhD, professor of medicine, director of the Diabetes Care Center, and chief of the division of endocrinology at the University of North Carolina School of Medicine in Chapel Hill, in a news release. “New treatment options are essential for the millions of adults with type 2 diabetes who continue to struggle to achieve optimal blood sugar control.”