Investigational compound dapagliflozin receives negative recommendation from FDA Advisory Committee

Bristol-Myers Squibb .Jul 20 2011

Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today reported the outcome of the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meeting on the New Drug Application for the investigational compound dapagliflozin.

“Do the efficacy and safety data provide substantial evidence to support approval of dapagliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus?”

On the question: "Do the efficacy and safety data provide substantial evidence to support approval of dapagliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus?" the Advisory Committee voted 6 yes and 9 no. Bristol-Myers Squibb and AstraZeneca remain committed to the dapagliflozin clinical development program and will continue to work closely with the FDA to support the review of this investigational compound.

Dapagliflozin is under joint development by Bristol-Myers Squibb and AstraZeneca. Dapagliflozin is being investigated as a monotherapy in addition to diet and exercise, and in combination with other anti-diabetic agents in addition to diet and exercise, to evaluate its effect on blood sugar levels (or HbA1c) in adults with type 2 diabetes. Dapagliflozin, an inhibitor of SGLT2, a target in the kidney, would potentially be the first in a new class of insulin-independent, oral type 2 diabetes agents.

The FDA Endocrinologic and Metabolic Drugs Advisory Committee based its voting on a review of data from the comprehensive dapagliflozin global clinical development program included as part of the FDA New Drug Application submission. This submission included data of up to two years in duration and involved approximately 6,000 individuals in 40 clinical studies. The trials were designed to evaluate the safety, tolerability and efficacy (as measured by HbA1c) of dapagliflozin in the approximately 4,200 patients who received dapagliflozin and were at various stages of the continuum of type 2 diabetes. In accordance with FDA guidelines, the New Drug Application also included data assessing the cardiovascular safety of dapagliflozin in adults with type 2 diabetes.

The FDA is not bound by the Advisory Committee's recommendation but takes its advice into consideration when reviewing New Drug Applications. The Prescription Drug User Fee Act (PDUFA) goal date for dapagliflozin is October 28, 2011.