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Cardiovascular Uncertainty Accompanies Canagliflozin To Advisory Panel

This article was originally published in The Pink Sheet Daily

Executive Summary

Janssen’s diabetes therapy also will undergo discussions about renal and bone fracture risks during a Jan. 10 meeting of FDA’s Endocrinologic and Metabolic Drugs Advisory Committee.

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Use Of Pre-Approval CV Data From Ongoing Trial Gets Once-Over At Canagliflozin Panel

There is no statistical reason not to allow a single trial to provide pre-approval and post-approval cardiovascular hazard ratios for a diabetes drug, FDA says, but Janssen’s canagliflozin would be the first. The Endocrinologic and Metabolic Drugs Advisory Committee backed approval 10-5.

Canagliflozin Should Have Limitations Based On Renal Function, Panel Says

Several advisory committee members on both sides of a 10-5 vote voiced concern about using Janssen’s diabetes drug in patients with moderate renal impairment.

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FDA’s rejection of Bristol-Myers Squibb and AstraZeneca’s diabetes drug dapagliflozin may mean new trials are needed, which would be a blow for the drug as well as a bad sign for the new class of SGLT2 inhibitors.

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