New York, July 31: Bristol-Myers Squibb (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) issued an approval on its new closely watched type 2 diabetes drug ONGLYZA™ (saxagliptin).
Onglyza belongs to a class of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, which work by stimulating the pancreas to produce more insulin after mealtimes. It is intended to be used with exercise and diet to control high blood sugar levels.
David Brennan, chief executive officer of AstraZeneca, said, "Type 2 diabetes is a daily challenge for adult patients and physicians. With the FDA approval of ONGLYZA, physicians and adult patients with type 2 diabetes have an important new treatment to help improve glucose control.”
Clinical development program
The FDA approval is based on a clinical development program, which included around 5,000 individuals of which more than 4,000 received Onglyza.
Throughout the development program, treatment with Onglyza produced clinically relevant and statistically significant reductions in glucose levels.
The drug is indicated as a once daily pill and can be used in combination with commonly prescribed oral anti-diabetic medications - metformin, sulfonylureas or thiazolidinediones - or as a monotherapy to significantly reduce glycosylated hemoglobin levels.
The FDA has asked for another study to be conducted on high risk diabetes patients to determine if there is actual cause for concern relating to heart health.
Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research stated, "Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with type 2 diabetes.
"High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease."
Common adverse reactions
According to the FDA, the most frequent side effects with Onglyza include infections of the upper respiratory or urinary tracts and headaches. In addition allergic reactions, such as rashes and hives can also occur.
Onglyza would compete with Januvia, another DPP-4 inhibitor which earned $1.4 billion last year.