Tags: diabetes | drug | heart | risk

FDA OKs Diabetes Drug to Reduce Heart Risk

FDA OKs Diabetes Drug to Reduce Heart Risk

(Copyright DPC)

Friday, 02 December 2016 03:06 PM EST

The U.S Food and Drug Administration said on Friday it would allow Eli Lilly and Co to state that its diabetes drug Jardiance reduces the risk of death from heart problems, potentially boosting the drug's sales.

Jardiance, 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.

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 results of that study showed Jardiance reduced the risk of cardiovascular death in patients when added to standard diabetes medications. That information can now be included on the drug's label.

When the drug's heart-protective data were announced last year, Sanford Bernstein analyst Tim Anderson more than tripled his annual sales forecast for the drug and combination drugs containing Jardiance to $2.7 billion by 2020.

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.

The risk of death from heart disease is 70 percent higher in diabetics compared to those without diabetes, according to the U.S. Centers for Disease Control and Prevention.

 

© 2026 Thomson/Reuters. All rights reserved.


Diabetes
The FDA has said it would allow the diabetes drug Jardiance to be used to reduce the risk of death from heart problems.
diabetes, drug, heart, risk
212
2016-06-02
Friday, 02 December 2016 03:06 PM
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