Approval marks second registration worldwide after Europe
UAE, Dubai - 13 November 2011 - Eli Lilly and Company, together with the Ministry of Health (MOH) in the UAE , announced today that Bydureon® (exenatide for prolonged release suspension for injection) has been granted registration approval in the UAE for the treatment of type 2 diabetes. Exenatide prolonged release - (Bydureon®) is the first once-weekly treatment for type 2 diabetes.
This registration approval was announced in a press conference under the theme of "Advancing Innovative Medicines". The press conference emphasized Lilly's commitment to advance innovation in the diabetes field and MOH commitment in providing the latest solutions to patients with diabetes in the UAE to help them reach their treatment goals
The MOH in the UAE is the second regulatory authority in the world to register exenatide prolonged release suspension (Bydureon® ) only behind the European Commission. "We are proud to be able to make available, to patients, doctors and healthcare professionals an innovative treatment for diabetes within few months of being registered in Europe," said Huzur Devletsah - general manager of Lilly for the Gulf Area. "This is only possible through effective collaboration and engagement of the ministry of health to advance patient care in the field of diabetes.".
Exenatide prolonged release suspension (Bydureon® ) for injection is indicated for the treatment of type 2 diabetes in combination with common oral therapies. Exenatide for prolonged release suspension (Bydureon® ) belongs to the class of glucagon-like peptide-1 (GLP-1) receptor agonists. Exenatide prolonged release suspension (Bydureon® )is delivered using a biodegradable microsphere technology developed by Alkermes. The medicine offers a continuous release of exenatide with just one weekly dose.
"Exenatide prolonged release suspension for type 2 diabetes (Bydureon® ) will answer an important unmet need for patients and healthcare professionals," said Joachim Becker- senior advisor- diabetes strategy - Lilly Emerging Markets. "Importantly, exenatide for prolonged release suspension will help patients achieve better glycaemic control in single weekly dose - giving them added confidence and freedom while managing type 2 diabetes."
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About Diabetes
It is estimated that by 2010, diabetes will affect 284.6 million adults worldwide and more than 55.4 million in Europe.[i],[ii] Approximately 90 to 95 percent of those are affected by type 2 diabetes, a condition characterized by failure of the pancreatic beta-cell to adequately respond to the increased demands for insulin that occur as a result of obesity-related insulin resistance.[iii]
Type 2 diabetes usually occurs in adults over the age of 40, but is increasingly common in younger people.[iv] In virtually every high-income country, diabetes is ranked among the leading causes of blindness, renal failure and lower limb amputation as well as one of the leading causes of death, largely because of a markedly increased risk of coronary heart disease and stroke (cardiovascular disease).[v]
About GLP-1 Receptor Agonists
To address the problem of rapid inactivation of glucagon-like peptide-1, scientists developed synthetic versions that resist inactivation by dipeptidyl peptidase-4 (DPP-4). GLP-1 receptor agonists, also called incretin mimetics, enhance insulin secretion in the presence of elevated glucose concentration, suppress the release of glucagon from the pancreas and improve the function of insulin-producing beta cells, resulting in improved glucose control.[vi] Also, GLP-1 receptor agonists have the potential for weight loss, as they inhibit appetite and reduce food intake.
The American Diabetes Association / European Association for the Study of Diabetes consensus treatment algorithm (2008) includes GLP-1 receptor agonists as recommended treatment options if initial lifestyle intervention and metformin fail to achieve or sustain glycaemic goals. According to the algorithm, GLP-1 receptor agonists could be considered especially when weight loss is a major consideration and hypoglycaemia is particularly undesirable.[vii]
About Exenatide Prolonged Release
Exenatide is the first and only once weekly therapy for the treatment of Type 2 Diabetes. It is an extended release medication designed to deliver a steady plasma concentration of exenatide in a single weekly dose. Exenatide prolonged release provides glyacemic control whenever blood glucose levels are elevated, offering the potential for improved HBA1C control with the added benefit of weight loss occurring in most patients.
Exenatide prolonged release is a once-weekly formulation of exenatide, the active in exenatide twice daily injection, which has been available in the U.S since 2005 and in Europe since 2007 and is used by more than 1.8 million patients in 70 countries worldwide to improve glycaemic control in adults with type 2 diabetes.
Important Safety Information for Exenatide
In clinical studies,among the most common side effects were nausea (feeling sick), hypoglycaemia (low blood sugar) when taken with a sulfonylurea, vomiting and diarrhea or constipation and injection site reactions. For the full list of all side effects reported with exenatide, see Summary of Product Characteristics. Exenatide should not be used in people who may be hypersensitive (allergic) to exenatide or any other ingredients of the medication.
About Amylin, Lilly and Alkermes
Amylin and Lilly partnered to develop and market exenatide prolonged release, which is based on proprietary technology for long-acting medications developed by Alkermes, Inc. exenatide prolonged release is approved in the EU and is under regulatory review in the U.S.
Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. Amylin's research and development activities leverage the Company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego and has a commercial manufacturing facility in Ohio.
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 1923, Lilly has been the industry leader in pioneering therapies to help healthcare professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.
Alkermes, Inc. is a fully integrated biotechnology company committed to developing innovative medicines to improve patients' lives. Alkermes' robust pipeline includes extended-release injectable and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. Headquartered in Waltham, Mass., Alkermes has a research facility in Massachusetts and a commercial manufacturing facility in Ohio.
[i] The International Diabetes Federation Diabetes Atlas. Available at: http://www.diabetesatlas.org/content/regional-overview. Accessed on March 23, 2011.
[ii] The International Diabetes Federation Diabetes Atlas. Available at: http://www.diabetesatlas.org/content/europe. Accessed on March 23, 2011.
[iii] Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA. 1999; 281 (21):2005-2012.
[iv] The International Diabetes Federation Diabetes Atlas. Available at http://www.diabetesatlas.org/content/what-is-diabetes. Accessed on March 23, 2011.
[v] The International Diabetes Federation Diabetes Atlas. Available at http://www.diabetesatlas.org/content/what-is-diabetes. Accessed on March 23, 2011.
[vi] Zander M, Christiansen A, Madsbad S, Holst JJ. Additive effect of glucagon-like peptide 1 and pioglitazone in patients with type 2 diabetes. Diabetes Care. 2004; 27: 1910-1914.
[vii] Nathan DM., Buse JB., Davidson MB., et al. Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy; A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2008:29:1963-1972.
© Press Release 2011
