Dapagliflozin Gains Strong FDA Panel Endorsement The Second Time Around
This article was originally published in The Pink Sheet Daily
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.
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A new frontier in diabetes care is set to open in India with the Special Expert Committee giving a green light to AstraZeneca’s dapagliflozin, after holding back on safety concerns for a prolonged period.
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.
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.