AZ’s Dapagliflozin Closes On Canagliflozin With India’s SEC Nod
This article was originally published in PharmAsia News
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.
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Lingering questions surrounding an imbalance in bladder cancer cases – and how FDA decides to handle the issue in labeling – could threaten the diabetes drug’s uptake, particularly given the absence of a similar signal for J&J’s competing SGLT-2 inhibitor Invokana, already on the market.
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.