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- Publication time:2016/12/5
Eli Lilly got a big boost for its diabetes drug franchise on Friday when the FDA approved its SGLT2 diabetes drug Jardiance to reduce the risk of cardiovascular death in adult patients with Type 2 diabetes and cardiovascular disease.
In approving the new indication, the FDA pointed out that cardiovascular disease is 70% higher in adults with diabetes and is often the cause of premature death for people with the condition.
“Availability of antidiabetes therapies that can help people live longer by reducing the risk of cardiovascular death is an important advance for adults with Type 2 diabetes,” Dr. Jean-Marc Guettier, director of the FDA’s Division of Metabolism and Endocrinology Products, said in the announcement.
An FDA advisory panel recommended the label extension in June, but just barely. The vote turned out to be 12-11 in favor, much closer than had been expected.
After that vote, Lilly execs told investors they expected to see an “inflection point” in sales. The company has been preparing sales reps with data to spread the word if approved and said they would promote any approval accordingly.
It is a bit of good news after a disappointing third quarter in which Eli Lilly CEO John Lechleiterreported that Lilly's diabetes workhorse, Humalog, saw sales fall 9% to $641 million, well below the $738 million analysts were expecting, because of deeper discounts and rebates demanded by payers and a hypercompetitive market.
Just last week there was more bad news when Lilly reported that its bet on its amyloid-busting drug solanezumab for mild Alzheimer's had failed, and that it had decided to abandon the drug.