Lilly's Jardiance snags FDA approval for reducing CV risk in Type 2 diabetes

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. In an outcomes trial, Jardiance showed that it could cut the risk of cardiovascular death by 38%.

“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 new indication in June, but just barely. The vote turned out to be 12-11 in favor, much closer than had been expected. As a result, Evercore ISI analyst Mark Schoenebaum pegged the likelihood of Lilly and partner Boehringer Ingelheim winning the nod at "coin flip odds."

Lilly now expects to see an “inflection point” in sales, execs have told investors. The company has been preparing sales reps with data to spread the word in the event of a green light and has said reps would promote any approval accordingly. Because Lilly grabbed a formal indication—rather than a simple addition of the outcomes data to Jardiance's label—Lilly should now be able to "be more aggressive in promoting the impressive results,” Credit Suisse analyst Vamil Divan wrote in a note to clients.

He expects treatment guidelines from the American Diabetes Association and other groups to shift in Jardiance’s favor as well, “setting the stage for greater Jardiance uptake”—particularly among primary care physicians.

It is a bit of good news after a disappointing third quarter in which Eli Lilly CEO John Lechleiter reported 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.