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Canagliflozin Should Have Limitations Based On Renal Function, Panel Says

 
• By Cathy Dombrowski

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.

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee backing for Janssen R&D LLC’s diabetes drug canagliflozin was tempered by recommendations from the Jan. 10 panel that its use be limited to patients with normal and mildly impaired renal function.

Several panel members on both sides of a 10-5 vote in favor of approval voiced concern that low efficacy in patients with moderate levels of renal impairment on top of the potential for additional renal damage produces a negative benefit/risk assessment

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