[Diabetes-talk] FW: [acb-diabetics] Bydureon pen for type2

[Mike Freeman]

From: acb-diabetics-bounces at acb.org [mailto:acb-diabetics-bounces at acb.org] On Behalf Of Nancy Matulis
Sent: Tuesday, March 04, 2014 1:06 PM
To: acb-diabetics at acb.org
Subject: [acb-diabetics] Bydureon pen for type2

 

The US Food and Drug Administration (FDA) has approved extended-release exenatide in a pen form for the treatment of adults with type 2 diabetes, according to the manufacturer.

AstraZeneca's exenatide extended release for injectable suspension ( Bydureon Pen) 2 mg is intended for once-weekly use as an adjunct to diet and exercise in the treatment of adults with type 2 diabetes.

The new prefilled pen contains the same extended-release formulation and dose of exenatide as the current single-dose tray (containing a 2-mg vial along with injecting equipment) but eases the self-injection process by eliminating the need for the patient to transfer the medication between vial and syringe.

AstraZeneca plans to make the Bydureon Pen available in the United States later in 2014. The single-dose tray will remain on the US market, the company said in a statement.

Extended-release exenatide can be given at any time of the day without regard to meals. No titration is required. The extended-release formulation of the glucagon-like peptide 1 agonist was first approved by FDA in 2012 and is now available in 42 countries, including those of the European Union.

In a 24-week randomized, open-label study of 252 adult patients with type 2 diabetes and inadequate glycemic control with diet and exercise alone, once-weekly exenatide injection produced a 1.6 percentage point reduction in hemoglobin A1c level compared with 0.9 percentage points for twice-daily injection ( Byetta). Nausea was less common with the once-weekly formulation, at 14% vs 35% for twice-daily.

Exenatide is not recommended as first-line therapy for type 2 diabetes. It is not a substitute for insulin and is not recommended for use with insulin. It should not be used in patients with type 1 diabetes or diabetic ketoacidosis.

The pen is only approved in the United States so far. An application was submitted for approval in the European Union at the end of 2013, and a decision is anticipated in the fourth quarter of 2014, a company spokesperson told Medscape Medical News.

 

Nancy Matulis

ACB Maine Secretary

Sent from my iPad

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