Invokana Development Directed By Mechanism Of Action
This article was originally published in Pharmaceutical Approvals Monthly
J&J’s canagliflozin is the first approval for a new pharmacologic approach to diabetes treatment, so FDA and the sponsor looked closely at the mechanism of action to identify safety questions – and to structure a clinical program that would provide data to answer them in the first review cycle.
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Bristol suggests FDA has had a change of heart on the evolving filing package for diabetes drug dapagliflozin. Meanwhile, the company sees no additional U.S. regulatory hurdles ahead for the eagerly awaited, novel oral anticoagulant Eliquis.
Even in the grip of the pandemic, review times for priority drugs were also consistent with the last three years.