Dapagliflozin Faces Ominous Prospect Of New Trials
This article was originally published in The Pink Sheet Daily
FDA’s rejection of Bristol-Myers Squibb and AstraZeneca’s diabetes drug dapagliflozin may mean new trials are needed, which would be a blow for the drug as well as a bad sign for the new class of SGLT2 inhibitors.
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Endocrinologic and Metabolic Drugs Advisory Committee will revisit concerns first discussed at 2011 meeting about bladder cancer risk with Bristol/AstraZeneca’s diabetes drug. Cardiovascular meta-analysis continues to suggest benefit but FDA questions what to make of “discordant” results from two studies in patients with CV disease.
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will consider a new submission for AstraZeneca/Bristol-Myers Squibb’s dapagliflozin on Dec. 12. Filing includes several new studies and more long-term data.
Bristol remains plagued by the loss of exclusivity for Plavix and setbacks in 2012, but the company hopes to paint a picture of growth as newly approved drugs begin to fill the revenue gap.