FDA rejection of Dapagliflozin creates uncertainty for other SGLT-2 inhibitors
This article was originally published in Scrip
Executive Summary
Dapagliflozin, the most advanced candidate in the novel SGLT-2 inhibitor antidiabetic class, was the subject of a complete response letter from the FDA, co-developers Bristol-Myers Squibb and AstraZeneca announced on 19 January 2012. The letter was not unexpected, given a negative 9-6 vote from an FDA Advisory Committee in July 2011 which revealed concerns about possible increased risks of breast and bladder cancers seen in the aggregated Phase II and Phase III trial data, as well as a case of probable drug-induced liver injury (scripintelligence.com, 21 July 2011).