FDA slaps down Novartis' blockbuster pitch for canakinumab — so what went wrong?
In a major setback, Novartis used its quarterly earnings report to flag an FDA slapdown on their application to market canakinumab for cardio risk reduction.
Touted as a blockbuster indication, the pharma giant steered this drug through a big late-stage development program, even pulling out data on a large subgroup of patients that could benefit from the drug. The then development chief Vas Narasimhan was promoted to CEO in part on the success he had with this drug — only to get hit with a complete response letter.
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