Dapagliflozin confirms leading role in new diabetes class as FDA accepts NDA
This article was originally published in Scrip
Executive Summary
Bristol-Myers Squibb and AstraZeneca confirmed their leadership position in the type 2 diabetes-focused sodium-glucose cotransporter 2 (SGLT2) inhibitor field with the FDA accepting the partners new drug application for dapagliflozin. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA is 28 October, 2011. At the end of January, the European Medicines Agency accepted for review a marketing authorisation application (MAA) for the compound to treat type 2 diabetes. The partners are co-developing the compound under a 2007 deal.