The Food and Drug Administration announced Thursday that it needs additional time to complete the review of the New Drug Application (NDA) for AstraZeneca and Bristol-Myers Squibb’s Onglyza (saxagliptin) for the treatment of type 2 diabetes.

 

More exactly, the FDA decided to extend the Prescription Drug User Fee Act date from April 30 to July 30. The companies had submitted the new drug application for Onglyza June 30 of the last year.

 

“The companies continue to work closely with the FDA to support the review of Onglyza,” Bristol-Myers and AstraZeneca said in a joint statement.

 

The drug received the approval of an FDA advisory panel earlier this month but the FDA does not have to follow the panel’s advice. The panel said the drug posed no excessive heart risk and could be a promising treatment, but said more data would be needed after approval to weigh any possible long-term risks.

 

If Onglyza gets the FDA clearance, it will rival Januvia, manufactured by Merck which is currently a leading drug for diabetes patients. Both Onglyza and Januvia aim to enhance the body’s ability to lower elevated blood sugar levels and are part of a class of drugs known as DPP-4 inhibitors.

 

An estimated 23.6 million Americans have diabetes, the leading cause of end-stage kidney disease. A balanced diet and lifestyle that includes regular exercise and weight loss for those who are overweight or obese slow the progression of diabetes’ complications.