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Invokana Development Directed By Mechanism Of Action

 
• By Bridget Silverman

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.

The novel mechanism of action of the sodium-glucose co-transporter 2 inhibitor class played a major role in the design of clinical trials for Johnson & Johnson’s Invokana;putting the mechanism first and foremost helped with regulatory issues as well as emphasizing the differentiation needed for the commercial sphere.

FDA review documents for Invokana show how the trials were designed to provide a complex set of analyses to explore theoretical risks and benefits suggested by the unfamiliar mechanism of...

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