FDA Advisory Committee recommends approval of Empagliflozin for cardiovascular indication

The US Food and Drug Administration (FDA) Advisory Committee has voted 12-11 that substantial evidence exists to establish that Jardiance® (empagliflozin) reduces cardiovascular (CV) death in adults with type 2 diabetes (T2D) and established CV disease. The recommendation was made by the Endocrinologic and Metabolic Drugs Advisory Committee based on data from the landmark EMPA-REG OUTCOME® trial, which found that Empagliflozin significantly reduced the risk of the combined endpoint of CV death, non-fatal heart attack or non-fatal stroke by 14% when added to standard of care in adults with T2D and established CV disease. The primary finding was driven by a 38% reduction in CV death, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. The overall safety profile was consistent with that of previous trials.

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‘Invokamet’ approved as First Line for Diabetes

FDA has approved ‘Invokamet’ which combines the sodium glucose cotransporter 2 (SGLT2) inhibitor canagliflozin with metformin hydrochloride for the first-line treatment of adults with type 2 diabetes. The new indication aligns with recent type 2 diabetes treatment guidelines, which recommend dual therapy for patients who have an initial HbA1c level of 7.5% or higher and for those who have an initial level below 7.5% and do not achieve an HbA1c treatment goal after about 3 months on single therapy, often metformin.

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