FDA lets Lilly cite Jardiance heart data, shares jump
WASHINGTON: US regulators said on Friday they would allow Eli Lilly and Co to state that its diabetes drug Jardiance reduces risk of death from heart problems, lifting company shares almost 3 percent and potentially giving a strong boost to the drug’s future sales.
Jardiance, a once-daily pill also known as empagliflozin, was approved by the FDA in 2014 to help lower blood sugar in patients with type 2 diabetes. It generated global sales of $48 million in the third quarter.
Lilly sells the drug in partnership with privately held German drugmaker Boehringer Ingelheim. At the time of approval the FDA asked that a separate trial be conducted to show the drug did not increase the risk of cardiovascular problems.
The study instead unexpectedly showed Jardiance slashed deaths by 32 percent in patients with type 2 diabetes at risk of heart attack and stroke, when added to standard diabetes medications. It was the first time any diabetes drug was shown to reduce risk of cardiovascular death. Moreover, patients taking Jardiance had a 35 percent lower rate of hospitalization for heart failure. That information can now be included on the drug’s label.