Well the results are in. In the sixth study of its kind pitting diabetes type 2 therapies in observation, Bydureon and Victoza went head to head comparing the measure A1C, an assessment of average blood sugar, and to evaluate safety and tolerability.
Over a time period of 26 weeks, patients received the max dose allowed for each medication. Results showed that patients receiving Bydureon experienced a reduction in A1C of 1.3 percentage points from baseline, compared to a reduction of 1.5 percentage points for Victoza.
Twenty percent of Victoza patients reported nausea, 11% vomiting and 13% diarrhea. Bydureon patients reported 9% nausea, 4% vomiting and 6% diarrhea respectively.
Gwen Krivi, M.D., vice president, product development, Lilly Diabetes comments:
“While this study did not meet its primary endpoint, these results reinforce the important role of GLP-1 receptor agonists in the treatment of type 2 diabetes. This is the sixth DURATION study showing once-weekly Bydureon had a significant A1C reduction from baseline. If approved, Bydureon could provide millions of patients a once-weekly treatment option.”
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.
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.
Source: Eli Lilly News Release
Written by Sy Kraft, B.A.