FDA delays AZ/B-MS Onglyza NDA review

Anglo-Swedish drug major AstraZeneca and the USA's Bristol-Myers Squibb have been told by the Food and Drug Administration that the agency needs  additional time to complete its review of the New Drug Application for  Onglyza (saxagliptin) in the treatment of type 2 diabetes.  The FDA has  extended the prescription drug user fee action date from April 30 to  July 30.

The drug is an investigational, selective, reversible inhibitor of the  dipeptidyl peptidase-4 enzyme under joint development by B-MS and  AstraZeneca.

The Onglyza application to the FDA includes use as a monotherapy, as an  adjunct to diet and exercise, use in combination with three types of  commonly-used oral antidiabetics - metformin, thiazolidinediones and  sulfonylureas when the single agent alone does not provide adequate  glycemic control, as an adjunct to diet and exercise - and use in  initial combination therapy with metformin, as an adjunct to diet and  exercise.