FDA Approves Bydureon BCise for Type 2 Diabetes Treatment
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The FDA has approved Bydureon BCise, a new form of the medication Bydureon, for treatment of type 2 diabetes. Created by AstraZeneca, one of the world’s largest pharmaceutical companies, Bydureon BCise is a new extended-release formulation of exenatide. It is a once weekly injectable in what the manufacturer describes as “an improved device, which has been demonstrated to provide significant blood sugar level reduction with the added benefit of weight loss.”
The new continuous release formula is a suspension that has a microsphere delivery system designed to provide consistent therapeutic levels of the active ingredient, exenatide, to help patients reach and maintain steady state.1 It’s expected to be available in the US during the first quarter of 2018.

Unique Delivery System

The medication is an antidiabetic agent known as an incretin mimetic. Typically prescribed for adult diabetics who have not had success controlling their HbA1c with diet, exercise and oral medication, it is an injectable drug that treats type 2 diabetes. You may be familiar with the term glucagon-like peptide 1 (GLP-1) receptor agonists, also known as GLP-1 analogues. This describes the way Bydureon BCise and other drugs in this class generally work. But this new continuous release formulation is not like other GLP-1s; its unique delivery system keeps the level of medication constant.

A1c Levels

HbA1c is glycated hemoglobin. Also referred to simply as A1c, it forms when hemoglobin, a blood cell protein that carries oxygen throughout your body, joins with glucose in the blood, becoming glycated. Doctors measure the A1c to determine average blood sugar levels over a period of time. The higher your A1c, the greater the risk of developing diabetes-related complications

How this class of drugs works

Called incretin mimetics, these drugs replace the function of the body’s natural incretin hormones to help lower blood sugar levels after eating. They stimulate the release of insulin by the pancreas after eating, inhibiting the release of glucagon by the pancreas, slowing glucose absorption into the bloodstream.

Autoinjectors combine convenience with efficiency

The new autoinjector has a hidden needle that makes Bydureon BCise convenient to use. It is a pre-filled, single dose device that is injected once a week. The medication is administered in three simple steps – mix, unlock, inject.1 It is not a first-line therapy and is not recommended for use with insulin. Like many medications, it can take time, 6-7 weeks, for the medication to reach its effective level in your bloodstream. Do not stop taking this medication, or any other, without first talking with your doctor.

Side effects

Studies conducted as part of the FDA approval process found that the most common side effects noted were nausea, and injection site nodules, little lumps that are not harmful and resolve themselves. Over 85% of study participants rated the injection task as easy or very easy to use.2

Contraindications

Bydureon BCise should not be prescribed to treat other types of diabetes such as type 1 diabetes or diabetic ketoacidosis. It should not be used with insulin, with any other exenatide products, or if you have a hypersensitivity to exenatide or any of its product compounds. A personal and/or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2) should be discussed with your physician.

view references
  1. US FDA approves new easy-to-use, once-weekly Bydureon BCise injectable medicine for patients with type-2 diabetes [news release]. Published October 23, 2017.  https://www.astrazeneca.com/media-centre/press-releases/2017/us-fda-approves-new-easy-to-use-once-weekly-bydureon-bcise-injectable-medicine-for-patients-with-type-2-diabetes-231017.html. Accessed online October 30, 2017.
  2. Incretin Mimetics (GLP-1 Agonists) Diabetes/co.uk website. http://www.diabetes.co.uk/diabetes-medication/incretin-mimetics.html. Accessed online October 30, 2017.
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