FDA Panel To Weigh Dapagliflozin Bladder Cancer, CV Safety Questions
This article was originally published in The Pink Sheet Daily
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.
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Members of the Endocrinologic and Metabolic Drugs Advisory Committee endorse approval of Bristol/AstraZeneca’s SGLT-2 inhibitor, believing that the ongoing 17,000-patient DECLARE trial will supply needed answers around cardiovascular and bladder cancer concerns.
In 13-1 vote, advisory committee backs Bristol/AstraZeneca’s SGLT-2 inhibitor for type 2 diabetes, saying that residual concerns about cardiovascular safety and bladder cancer will be clarified with planned and ongoing post-marketing studies; approval recommendation follows a negative panel vote in 2011.
J&J is the first pharma company to bring an SGLT2 inhibitor to market, but its window of exclusivity in that class may be narrow, given that FDA is slated to assess two other SGLT2s later this year.