Thursday, November 9, 2017

FDA Approves Once-Weekly Bydureon BCise (exenatide) for Patients with Type-2 Diabetes

 In continuation of my update on exenatide. AstraZeneca announced that the US Food and Drug Administration (FDA) has approved Bydureon® BCise™ (exenatide extended-release) injectable suspension, a new formulation of Bydureon (exenatide extended-release) injectable suspension in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabeteswhose blood sugar remains uncontrolled on one or more oral medicines inaddition to diet and exercise, to improve glycemic control.

Unlike other glucagon-like peptide-1 (GLP-1) receptor agonists, Bydureon BCise has a unique, continuous-release microsphere delivery system designed to provide consistent therapeutic levels of the active ingredient, exenatide, to help patients reach and maintain steady state. The new formulation in the innovative Bydureon BCise device is proven to reduce blood sugar levels, with the added benefit of weight loss, although 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 anti-diabetic medicines at 28 weeks. The most common adverse reactions reported in ≥5% of patients in clinical trials were nausea (8.2%) and adverse events associated with injection-s te nodules (10.5%).

Bydureon BCise is designed for ease and patient convenience in a once-weekly, pre-filled device with a pre-attached hidden needle. The medication is administered in three simple steps – mix, unlock, inject.

Ruud Dobber, President, AstraZeneca US and Executive Vice President, North America, said: “We know that physicians have established  longstanding confidence in the significant HbA1c reduction Bydureon  provides their patients to help achieve consistent control, with the  added benefit of weight loss. With the approval of Bydureon BCise, we’re  now introducing a new formulation in an improved, easy-to-use device, that will help enhance the patient experience.”
Bydureon BCise will be available for patients in the US in the first  quarter of 2018. Bydureon Pen will also remain available for patients. A regulatory application for the new autoinjector device has also been accepted by the European Medicines Agency.

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