April 3, 2018 AstraZeneca today announced the US Food and Drug Administration (FDA) has approved Bydureon (exenatide extended-release) for injectable suspension as an add-on therapy to basal insulin in adults with type 2 diabetes (T2D) with inadequate glycemic control. Bydureon is approved for adults with T2D whose blood sugar remains uncontrolled on one or more antidiabetic medicines in addition to diet and exercise, to improve glycemic control.
The expanded use is based on results from the 28-week DURATION-7 study, which examined the effect of Bydureon or placebo as add-on therapy to insulin glargine, with or without metformin, in adults with T2D. Mean HbA1c was reduced by 0.9% in the Bydureon group (n=231) compared to 0.2% in the placebo group (n=229; between-group difference of 0.6%, p<0.001) in patients with a mean baseline HbA1c of 8.5%. Furthermore, 32.5% of patients in the Bydureon group reached an HbA1c of <7.0% compared to 7.0% of patients in the placebo group.
There were no new safety findings in the DURATION-7 study. Overall hypoglycemia was similar between the groups (Bydureon 29.7% and placebo 29.0%), with no reported major hypoglycemia. In both arms, the same percentage of patients reported minor hypoglycemia (5.6%). Like other GLP-1 receptor agonists (RA), the risk of hypoglycemia is increased when Bydureon is coadministered with insulin. Prescribers should consider lowering the dose of insulin when coadministering Bydureon.
The most common adverse events (≥5%) and occurring more frequently than comparator in Bydureon clinical trials are nausea (16.9%), diarrhea (12.7%), headache (8.0%), vomiting (6.8%), constipation (5.9%), injection-site pruritus (5.9%), injection-site nodule (5.3%), and dyspepsia (5.1%).
Jim McDermott, PhD, Vice President, US Medical Affairs, Diabetes at AstraZeneca, said: “Type 2 diabetes is a complex disease for patients and health care 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. The DURATION-7 study is part of the broader DURATION clinical trial program which continues to yield vital insights on the use of exenatide. 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.”
Both the American Diabetes Association and the American Association of Clinical Endocrinologists support the use of a GLP-1 RA in combination with basal insulin and metformin in appropriate patients to help manage type 2 diabetes.1,2
Bydureon is a once-weekly GLP-1 RA injectable for adults with type 2 diabetes, intended to help the body produce more insulin in response to an increase in glucose, reduce glucagon production and slow gastric emptying, to assist in reducing hyperglycemia. Bydureon was first approved by the FDA in January 2012.
About AstraZeneca in Diabetes
AstraZeneca is pushing the boundaries of science with the goal of developing life-changing medicines that aim to reduce the global burden and complications of diabetes. As a main therapy area for the company, we are focusing our research and development efforts on diverse populations and patients with significant co-morbidities, such as cardiovascular disease, obesity, non-alcoholic steatohepatitis (NASH), and chronic kidney disease.
Our commitment to diabetes is exemplified by the depth and breadth of our global clinical research program. This commitment is advancing the understanding of the treatment effects of our diabetes medicines in broad patient populations, as well as exploring combination products to help more patients achieve treatment success earlier in their disease.
About AstraZeneca in Cardiovascular, Renal & Metabolic Diseases (CVRM)
Cardiovascular, renal and metabolic diseases together form one of AstraZeneca’s main therapy areas and platforms for future growth. By following the science to understand more clearly the underlying links between the heart, kidney and pancreas, AstraZeneca is investing in the development of a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. Our ambition is to modify or halt the natural course of CVMDs and even regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CVMD health for millions of patients worldwide.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of Autoimmunity, Neuroscience and Infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.
- ADA: American Diabetes Association. Standards of Medical Care in Diabetes–2018. Diabetes Care. 2018;41 (Suppl1):S73-S85.
- Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm – 2018 executive summary. Endocr Pract. 2018;24(1):91-120.
Posted: April 2018
- FDA Approves Once-Weekly Bydureon BCise (exenatide) for Patients with Type-2 Diabetes – October 23, 2017
- FDA Approves Bydureon Pen for Once-Weekly Treatment of Adults with Type 2 Diabetes – March 3, 2014
- FDA Approves Bydureon – The First and Only Once-Weekly Treatment for Type 2 Diabetes – January 27, 2012
- Bydureon FDA Action Date Set for January 28, 2012 – August 10, 2011
- Bydureon Reply Submitted to FDA – July 28, 2011
- Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for Bydureon – October 20, 2010
- Bydureon FDA Review Timeline Set with PDUFA Action Date of October 22, 2010 – May 6, 2010
- Amylin, Lilly and Alkermes Submit Reply to FDA Complete Response Letter for Bydureon – April 23, 2010
Bydureon (exenatide) FDA Approval History