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FDA Used Invokana Review To Reflect On Diabetes CV Risk Policy

 
• By Bridget Silverman

Agency officials viewed the review of canagliflozin – the first program started after the 2008 outcomes trial requirement – as a chance to look at lessons learned since the policy went into effect.

As the first drug approved with full implementation of FDA’s cardiovascular risk requirements for diabetes drugs, the review of Johnson & Johnson’s Invokana (canagliflozin) provided an opportunity for FDA to reflect on how diabetes programs that incorporate risk assessment from the outset should be conducted, rather than parsing data from retrofitted or inadequate trial programs.

FDA’s 2008 guidance requiring cardiovascular risk assessment for anti-diabetics was one of the most seismic regulatory events of the past decade, and it left sponsors grappling with how to add...

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