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WASHINGTON -- The diabetes drug in patients with type 2 diabetes and co-existing cardiovascular disease, the FDA said Friday.
It's the first such claim ever allowed for a diabetes drug.
Empagliflozin, first approved in 2014, is an inhibitor of the sodium-glucose co-transporter 2 (SGLT2) pathway, reducing blood glucose by causing it to be excreted in urine.
Its benefit for cardiovascular risk reduction was demonstrated in the so-called EMPA-REG trial, results of which were reported in 2015.
But whether the FDA would approve the indication was unclear, after an advisory committee delivered a split vote in June. Members opposing the claim pointed to problems with the trial that included interim unblinding, protocol changes, and irregularities in some of the data.
In announcing the approval, the agency said the "availability of anti-diabetes therapies that can help people live longer by reducing the risk of cardiovascular death is an important advance for adults with type 2 diabetes."
The announcement also noted that the drug "is not intended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis." It also recited the list of contraindications and adverse effects already noted on the drug's label.
Since the EMPA-REG results were released, trials of two other diabetes drugs -- liraglutide (Victoza) and the investigational drug semaglutide -- also have demonstrated a cardiovascular benefit.