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Easier-to-Use Formulation of Bydureon Wins FDA’s Blessing
A new formulation of extended-release (ER) exenatide in an improved once-weekly, single-dose autoinjector has won FDA approval for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise.
AstraZeneca announced the approval of Bydureon BCise injectable suspension, a new formulation of Bydureon. Unlike other glucagon-like peptide-1 receptor agonists, Bydureon BCise has a continuous-release microsphere delivery system designed to provide consistent therapeutic levels of exenatide to help patients reach and maintain steady state. The new formulation is proven to reduce blood sugar levels, with the added benefit of weight loss (although it is not a weight loss medicine).
Across two clinical trials, average HbA1c reductions of up to 1.4% and average weight loss of up to 3.1 pounds were achieved when used as monotherapy or as an add-on to metformin, a sulfonylurea, a thiazolidinedione, or any combination of two of these oral antidiabetic medicines at 28 weeks. The most common adverse reactions reported in at least 5% of patients in clinical trials were nausea (8.2%) and adverse events associated with injection-site nodules (10.5%).
Bydureon BCise, provided in a once-weekly, pre-filled device with a pre-attached hidden needle, is administered in three steps—mix, unlock, inject. The new formulation and device “will help enhance the patient experience,” said Ruud Dobber, President of AstraZeneca US and Executive Vice President, North America.
Bydureon BCise will be available for patients in the U.S. in the first quarter of 2018. Bydureon Pen will also remain available for patients.
Bydureon and Bydureon BCise are both indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. They are not recommended as first-line therapy for patients inadequately controlled on diet and exercise and should not be used to treat type-1 diabetes or diabetic ketoacidosis
Exenatide ER carries a boxed warning for an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether the medication causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined. The drug is contraindicated in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2.
Source: AstraZeneca; October 23, 2017.