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FDA panel backs J&J's canagliflozin

January 11, 2013 12:59 AM UTC

FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 10-5 to recommend approval of diabetes product Invokana canagliflozin from Johnson & Johnson (NYSE:JNJ). Four of the panel members who voted against approval said their main concern was approval for a broad indication, as they felt the benefit-risk profile of Invokana in diabetes patients with moderate renal impairment did not support approval. The panel voted 8-7 that concerns remain regarding whether J&J had provided sufficient evidence of cardiovascular safety for Invokana. Panelists were also concerned about a higher incidence of stroke with Invokana patients, although it was not statistically significant. ...