FDA Advisory Committee recommends Invokana (canagliflozin ) from Janssen Pharma as a treatment for Type 2 Diabetes
The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 10-5 to recommend approval for canagliflozin from Janssen Pharmaceuticals with the proposed trade name Invokana, to treat Type 2 Diabetes in adult patients based on the efficacy and safety results from its comprehensive clinical development program.
The committee also voted 8 to 7 that they had concerns about potential cardiovascular risks, while some panel members recommended that patients with impaired kidneys should not be given the drug. Concern was also expressed about bone related side effects.
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