A staff report posted on the U.S. Food and Drug Administration website revealed that new drug saxagliptin from Bristol-Myers Squibb Co. and AstraZeneca PLC did not cause an increase in risk for cardiovascular conditions such as heart attack and stroke, a side effect which has been observed in other diabetes drugs.
The review was released in advance of a scheduled Endocrinologic and Metabolic Drugs Advisory Committee meeting on April 1.
Since 2008, the FDA adopted more stringent standards for reviewing anti-diabetic medication, asking companies to prove that their drug will not trigger an increase in risk for heart attack or stroke. In June, the agency increased their safety requirements even further after the controversy that surrounded the drug Avandia (rosiglitazone), which was said to trigger an increase in the risk for cardiovascular conditions.
The new pill was able to meet the cardiovascular safety guidelines set by the FDA. The Advisory Committee meeting will consider these findings and will provide their opinions on the data, which were taken from trials that were not designed to evaluate such risks. They will not be asked to take a vote on an overall approval recommendation for the drug.
Drug manufacturers are actively developing new diabetes treatments for the estimated 24 million Americans suffering from the disease, especially since older therapies have been seen to cause heart risks.
Saxagliptin is similar to the Merck drug Januvia, a DPP-4 inhibitor. Januvia is a treatment for Type 2 diabetes by stimulating the pancreas to produce more insulin and the liver to produce less glucose.
There were eight studies conducted. In four studies, patients were given either saxagliptin or placebo; in three, saxagliptin was added to an existing anti-diabetic treatment; and the last study consisted of patients receiving a combination of saxagliptin and metformin.