Le Lézard
Classified in: Health
Subjects: BFA, FDA

BYDUREON® BCisetm Injectable Medicine Now Available In The US For Patients With Type-2 Diabetes



WILMINGTON, Del., Jan. 10, 2018 /PRNewswire/ -- AstraZeneca today announced that BYDUREON® BCisetm (exenatide extended-release) injectable suspension 2mg is now available in pharmacies across the United States. BYDUREON BCise was recently approved by the U.S. Food and Drug Administration for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral antidiabetic medicines in addition to diet and exercise, to improve glycemic control.

Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8230251-astrazeneca-bydureon-bcise-available-for-type-2-diabetes/

BYDUREON BCise is a new formulation of BYDUREON® (exenatide extended-release) injectable suspension 2mg in an improved once-weekly, single-dose autoinjector device. It is designed for patient ease and convenience in a pre-filled device with a pre-attached hidden needle. The new formulation of BYDUREON BCise is proven to reduce blood sugar levels and may have the added benefit of weight loss, although not a weight loss medicine. The medication is administered in three simple steps ? mix, unlock, inject.

Rod Wooten, Vice President, Cardiovascular and Metabolic Diseases, AstraZeneca, said: "We're pleased that BYDUREON BCise, a new once-weekly treatment option in an easy-to-use device, is now available for adults with type 2 diabetes. This new formulation helps to provide consistent glycemic control, in addition to the powerful HbA1c reductions and added benefit of weight loss, now in a simply improved device."

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 ?5% of patients in clinical trials were nausea (8.2%) and adverse events associated with injection-site nodules (10.5%).

Virginia Valentine APRN, BC-ADM, CDE, FAADE, said: "Managing type 2 diabetes is complicated and requires daily attention to meal planning, exercise and medications. A once-weekly prescription option in an easy-to-use device, like BYDUREON BCise, can help simplify a patient's regimen and help them achieve diabetes control goals."

AstraZeneca is committed to supporting patient access to BYDUREON BCise. Eligible commercially insured patients may pay as low as $0 for BYDUREON BCise every month. For more information visit www.BydureonBCise.com.

INDICATION AND LIMITATIONS OF USE

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

IMPORTANT SAFETY INFORMATION ABOUT BYDUREON AND BYDUREON BCISE, INCLUDING BOXED WARNING

WARNING: RISK OF THYROID C-CELL TUMORS

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

DRUG INTERACTIONS

PREGNANCY
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Please see full Prescribing Information and Medication Guide for BYDUREON BCISE and full Prescribing Information and Medication Guide for BYDUREON.

NOTES TO EDITORS

About AstraZeneca in Diabetes
AstraZeneca is pushing the boundaries of science with the goal of developing life-changing medicines that aim to reduce the global burden and complications of diabetes. As a main therapy area for the company, we are focusing our research and development efforts on diverse populations and patients with significant co-morbidities, such as cardiovascular disease, obesity, non-alcoholic steatohepatitis (NASH), and chronic kidney disease.

Our commitment to diabetes is exemplified by the depth and breadth of our global clinical research program. This commitment is advancing the understanding of the treatment effects of our diabetes medicines in broad patient populations, as well as exploring combination products to help more patients achieve treatment success earlier in their disease.

About AstraZeneca in Cardiovascular, Renal & Metabolic Diseases (CVMD)
Cardiovascular, renal and metabolic diseases together form one of AstraZeneca's main therapy areas and platforms for future growth. By following the science to understand more clearly the underlying links between the heart, kidney and pancreas, AstraZeneca is investing in the development of a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. Our ambition is to modify or halt the natural course of CVMDs and even regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CVMD health for millions of patients worldwide.

About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of Autoimmunity, Neuroscience and Infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

CONTACTS




Media Inquiries


Michele Meixell

+1 302 885 2677

Abigail Bozarth

+1 302 885 2677

 

SOURCE AstraZeneca


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