Conference Coverage
FDA panel narrowly endorses empagliflozin’s cardiovascular mortality benefit
In a 12-11 vote, a Food and Drug Administration advisory panel narrowly came down in favor of the agency adding a new labeling entry to the...
“An FDA-approved indication for reduction in cardiovascular death would be influential with physicians and patients,” predicted Dr. Fonarow.
A FDA imprimatur on the cardiovascular mortality benefit would help buttress belief in the EMPA-REG OUTCOME result and might help drive better reimbursement coverage. A thumbs down will likely dampen enthusiasm in and practicality of the treatment until additional, corroborative data appear.
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