FDA Panel to Vote Whether Diabetes Drug Cuts Cardiac Death
An advisory panel to the U.S. Food and Drug Administration will be asked to vote next week on whether a diabetes drug made by Eli Lilly & Co and Boehringer Ingelheim cuts the risk of cardiovascular death, according to documents posted on the agency’s website on Friday.
The documents were published ahead of a June 28 meeting of outside advisors who will discuss the drug, Jardiance, and recommend whether the label should include a claim that it cuts the risk of heart problems in patients at high risk.
The FDA is not obliged to follow the advice of its advisory panels but typically does so.
The FDA approved Jardiance, known also as empagliflozin, in 2014 to help lower blood sugar in patients with type 2 diabetes. But it also asked the companies to conduct an additional clinical trial to show it did not increase the risk of heart problems.
In January, the companies submitted their results, which showed the drug actually cut the risk of death from heart attacks and strokes, becoming the first glucose-lowering drug to show protective results in a large clinical trial.
Now, the companies want to add those results to the drug’s label and claim it improves cardiovascular outcomes in patients at high risk of a heart attack or stroke.
The data showed Jardiance cut the combined risk of cardiac death, non-fatal heart attacks and non-fatal strokes by 14 percent. It cut the risk of death from any cause by 32 percent… Read More>>