When was byetta fda approved




















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Search Menu. Search Search Search Close. About GLP-1 Receptor Agonists An agonist is a molecule, such as a drug or a hormone, which binds to a receptor of a cell and triggers a response by that cell. All rights reserved. The US Food and Drug Administration FDA has approved exenatide Byetta , the type 2 diabetes drug, as an additional therapy for diabetic adults who are already dieting, exercising, and taking insulin glargine. According to co-developers Amylin Pharmaceuticals and Eli Lilly , this approval makes exenatide the first GLP-1 receptor agonist obtainable for use with insulin glargine with or without metformin or a thiazolidinedione to attain glycemic control.

Find out more about how we use cookies and how to manage them by reading our cookie notice. Food and Drug Administration FDA in , headlines over the following few days highlighted its unique origin:. Though the Gila monster may have led the news, the real story was that with the approval of BYETTA, adult patients with type 2 diabetes T2D and prescribers had a new class of diabetes treatment — called glucagon-like peptide-1 receptor agonists, or GLP-1 RAs. The GLP-1 RA class was a new therapeutic option that worked differently from other diabetes medications available at that time.

Everyone was excited about the approval, because they knew BYETTA offered another critical treatment option that could help a large number of adults with type 2 diabetes manage the condition. Exenatide is the synthetic version of a protein called exendin-4, which comes from the saliva of the Gila monster.

Ralph DeFronzo was an early investigator and adopter of exenatide. Exenatide-based products are now marketed in more than 80 countries worldwide, and it is estimated that more than 2 million people have used exenatide products since the launch of BYETTA. Over the past 10 years, the GLP-1 receptor agonist class has grown to include five marketed products in the U. Diabetes is projected to affect more than million people by To help address the treatment needs of people with diabetes, AstraZeneca will continue to push the boundaries of science in an effort to create life-changing medicines.

BYETTA is an injectable prescription medicine that may improve blood sugar glucose control in adults with type 2 diabetes, when used with diet and exercise. BYETTA should not be used in people with type 1 diabetes or people with diabetic ketoacidosis a condition caused by very high blood sugar.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www. A recording will be available by phone for 24 hours beginning approximately one hour after the close of the call and can be accessed at domestic or international , conference ID number Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines.

Further information on Amylin Pharmaceuticals, its marketed products, and its pipeline in metabolism is available at www. Through a long-standing commitment to diabetes care, Lilly provides patients with breakthrough treatments that enable them to live longer, healthier and fuller lives.

Since , Lilly has been the industry leader in pioneering therapies to help health care professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients.

For more information about Lilly's current diabetes products visit www. Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations.

Headquartered in Indianapolis, Ind. Additional information about Lilly is available at www. This press release contains forward-looking statements about Amylin and Lilly.

The potential for BYETTA may also be affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance and any issues related to manufacturing and supply. These and additional risks and uncertainties are described more fully in Amylin and Lilly's most recently filed SEC documents such as their Annual Reports on Form K.

Amylin and Lilly undertake no duty to update these forward-looking statements.



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