Well the results are in and the European Union as approved Byuderon, the only drug of its kind to treat diabetes 2 in a once a week with a single dosage. In the United States earlier this year, and in the sixth study of its kind, pitted two diabetes type 2 therapies in observation, Byuderon and Victoza went head to head comparing the measure A1C, an assessment of average blood sugar, and to evaluate safety and tolerability. This serves as a potential precursor for US/FDA approval later this year.
GLP-1 drugs are expected to grab a big share of the growing market, and analysts are now betting that Bydureon, a long-acting version of Byetta that is injected once a week, will be a likely star performer. Sales estimates are all over the map, ranging from $1 billion to a heady $6 billion, demonstrating once again how hard it is to predict anything in the biopharma world. But there’s considerable consensus that the three companies partnered on this program are going to come out well ahead. Bydureon is a particularly crucial product for Eli Lilly.
The New Drug Application for Bydureon was submitted to the U.S. Food and Drug Administration (FDA) in 2009. The FDA issued a complete response letter and requested further data in October 2010. The companies plan to submit a response in the second half of 2011.
Enrique Conterno, president, Lilly Diabetes adds:
“As the global impact of diabetes continues to expand, so does the need for innovative medicines to help people living with diabetes successfully fit treatment into their lives. Bydureon is the first and only once-weekly treatment for type 2 diabetes and has demonstrated powerful efficacy in multiple clinical trials.”
Type 2 diabetes is the most common form of diabetes. Millions of Americans have been diagnosed with type 2 diabetes, and many more are unaware they are at high risk. Some groups have a higher risk for developing type 2 diabetes than others. Type 2 diabetes is more common in African Americans, Latinos, Native Americans, and Asian Americans, Native Hawaiians and other Pacific Islanders, as well as the aged population.
In type 2 diabetes, either the body does not produce enough insulin or the cells ignore the insulin. Insulin is necessary for the body to be able to use glucose for energy. When you eat food, the body breaks down all of the sugars and starches into glucose, which is the basic fuel for the cells in the body. Insulin takes the sugar from the blood into the cells. When glucose builds up in the blood instead of going into cells, it can lead to diabetes complications.
Diabetes affects nearly 26 million people in the U.S. and an estimated 285 million adults worldwide. Approximately 90to 95% of those affected have type 2 diabetes. Diabetes costs approximately $174 billion per year in direct and indirect medical expenses.
According to the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey, approximately 60% of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.
The American Diabetes Association sets certain guidelines for normal and abnormal blood glucose levels. However, if you have diabetes, a doctor may set different ranges for you. Young children may have slightly higher target ranges than stable adults and those starting out on insulin pump therapy or are newly diagnosed with diabetes may initially have higher target ranges to help avoid hypoglycemia during the initial phase of insulin pumping.
Sources: News Release and Eli Lilly
Written by Sy Kraft