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.
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.
The result was driven by a 38-percent reduction in the risk of cardiac death. There was no significant difference in the risk of non-fatal heart attack or non-fatal stroke, potentially muddying the waters for what the company is allowed to claim.
The FDA will ask the panel whether it believes a single adequate and well-controlled trial is enough to establish that the drug cuts heart risk.
The agency said efficacy claims usually require more than one trial, “though there are situations in which a single adequate and well-controlled study has served as the basis for a claim.”
Jardiance belongs to a new family of treatments called SGLT2 inhibitors that include Johnson & Johnson’s $1.3 billion-a-year Invokana and AstraZeneca Plc’s Farxiga.
“Look for the FDA panel to be a battle of “statistical purists” vs “clinicians,” Seamus Fernandez, an analyst at Leerink, said in a recent research note to investors.