FDA Approves Bydureon Pen
FDA Approves Bydureon Pen for Once-Weekly Treatment of Adults with Type 2 Diabetes
Monday March 3, 2014 -- AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved the Bydureon Pen (exenatide extended-release for injectable suspension) 2 mg as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Bydureon should not be used for treatment of patients with type 1 diabetes or diabetic ketoacidosis. Bydureon is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Bydureon is not a substitute for insulin. The concurrent use of Bydureon with insulin has not been studied and is not recommended.
Bydureon is the first and only once-weekly medicine for adults with type 2 diabetes. The Bydureon Pen is a pre-filled, single-use pen injector, eliminating the need for the patient to transfer the medication between a vial and syringe during the self-injection process. The Bydureon Pen contains the same formulation and dose as the original Bydureon single-dose tray, providing the same continuous release of exenatide. Bydureon has been shown to provide powerful HbA1c (blood glucose level) reduction. In a 24-week, randomized, open-label trial, once-weekly Bydureon demonstrated an HbA1c reduction of 1.6 percentage points vs 0.9 percentage points for twice-daily Byetta® (exenatide) injection at 24 weeks (baseline HbA1c 8.5% and 8.4%, respectively). Additionally, Bydureon demonstrated a mean weight reduction of 5.1 pounds (2.3 kg) vs 3.1 pounds (1.4 kg) with Byetta (baseline 213.8 pounds [97 kg] and 207.2 pounds [94 kg], respectively). Bydureon is not indicated for the management of obesity, and weight change was a secondary endpoint in clinical trials.
The Prescribing Information for Bydureon includes a Boxed Warning regarding the risk of thyroid C-cell tumors. It is unknown whether Bydureon causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be determined by clinical or nonclinical studies. Bydureon is contraindicated in patients with a personal or family history of MTC, in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), or history of a serious hypersensitivity reaction to exenatide.
Based on post-marketing data, exenatide has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, Bydureon should be discontinued promptly and not restarted if pancreatitis is confirmed. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Bydureon and Byetta contain the same active ingredient and should not be used together.
“We are 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,” said Briggs Morrison, M.D., executive vice president, Global Medicines Development and chief medical officer, AstraZeneca. “We are committed to addressing the needs of adults with type 2 diabetes, including ongoing research to develop new treatments and methods of delivery.”
The Bydureon Pen delivers exenatide via microsphere technology in a once-weekly dose requiring no titration. It can be administered at any time of the day, with or without meals. Prior to initiation of the Bydureon Pen, patients should be trained by their healthcare professional.
AstraZeneca plans to make the Bydureon Pen available for patients later this year. The Bydureon single-dose tray will remain on the market for patients prescribed Bydureon.
About Bydureon Clinical Development Program
The FDA approval of Bydureon was based on the safety and efficacy data from the pivotal DURATION-5 clinical trial, in which treatment with Bydureon resulted in improvements in glycemic control. The DURATION-5 trial was a randomized open-label clinical study of 252 adult patients with type 2 diabetes and inadequate glycemic control with diet and exercise alone or with oral antidiabetic therapy, including metformin, a sulfonylurea, a thiazolidinedione, or a combination of two of these oral type 2 diabetes medications comparing Bydureon to Byetta (n = 129 and n = 123, respectively). After 24 weeks of treatment, patients taking once-weekly Bydureon experienced a 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. HbA1c is a measure of average blood sugar over three months. Both treatment groups achieved a reduction in weight by the end of the study, with an average loss of 5.1 pounds or 2.3 kg (213.8 pounds or 97 kg baseline) for patients taking Bydureon and 3.1 pounds or 1.4 kg (207.2 pounds or 94 kg baseline) for patients taking Byetta (change in weight was a secondary endpoint). The most frequently reported adverse event in both groups was nausea, reported less frequently by Bydureon users (14%) than by Byetta users (35%). Other common treatment-emergent adverse events in the Bydureon group included diarrhea (9.3% vs 4.1%) and injection-site erythema (5.4% vs 2.4%, respectively). There were no major hypoglycemic events in either treatment arm. Minor episodes of hypoglycemia occurred in Bydureon 2 mg and Byetta 10 mcg patients with concomitant sulfonylurea use (12.5% vs 11.8%, respectively).
The FDA approval for Bydureon was received in 2012. Bydureon is currently available in 42 countries worldwide, including European Union countries.
About GLP-1 Receptor Agonists
An agonist is a molecule, such as a drug or a hormone, which binds to a receptor of a cell and triggers a response by that cell. A glucagon-like peptide-1 (GLP-1) receptor agonist binds to and activates the GLP-1 receptor, which exhibits multiple anti-hyperglycemic actions.
About Type 2 Diabetes
Diabetes is estimated to affect 25.8 million people in the U.S. and more than 382 million people worldwide. The prevalence of diabetes is projected to reach more than 592 million people worldwide by 2035. Type 2 diabetes accounts for approximately 90-95 percent of all cases of diagnosed diabetes. Type 2 diabetes is a chronic disease characterized by pathophysiologic defects leading to elevated glucose levels. Over time, this sustained hyperglycemia contributes to further progression of the disease. Significant unmet needs still exist, as many patients remain inadequately controlled on their current glucose-lowering regimen.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.
Posted: March 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