Lilly nets best-case Jardiance nod from FDA, clearing reps to talk up CV risk reduction

Jardiance
Eli Lilly and Boehringer Ingelheim's SGLT2 med Jardiance has won a new FDA indication for reducing the risk of cardiovascular death in Type 2 diabetes patients.

Good news for Eli Lilly: It’s snagged a new indication for SGLT2 contender Jardiance, meaning its reps can now directly promote its claims that the med reduces the risk of cardiovascular death in Type 2 diabetes patients. And with that, the company should see the “inflection point” in sales that it's been waiting for, analysts predict.

Regulators handed down the positive decision Friday, citing the 38% reduction in cardiovascular death the med—which Lilly shares with partner Boehringer Ingelheim—posted in its EMPA-REG outcomes trial.

It was hardly a sure thing, though. In June, an FDA panel of experts only narrowly recommended the new indication, voting by a tally of 12-11. The agency’s final verdict represents a best-case scenario for the the drugmakers; the FDA might have simply added the outcomes data to Jardiance’s label rather than backing a formal indication. Even worse, Lilly and Boehringer might have been stuck waiting until 2017, when results from an outcomes study of Johnson & Johnson’s competitor Invokana are due, Credit Suisse analyst Vamil Divan wrote in a note to clients.

Instead, the new nod should now “allow for Lilly to be more aggressive in promoting the impressive results” of EMPA-REG, he said. 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.

The way Evercore ISI analyst John Scotti sees it, the indication bodes well not only for Jardiance, but for “the SGLT2 class as a whole.” And the class, which includes AstraZeneca’s Forxiga in addition to Invokana and Jardiance, could use the boost; Lilly’s diabetes head, Enrique Conterno, has acknowleged more than once to investors that the class has been expanding at a slower rate than Lilly had expected.

The go-ahead also represents a validation of the tack Lilly recently decided to take in relation to Glyxambi, its SGLT2-DPP-4 combo med. Last month, Conterno told shareholders the company was holding off on investing in Glyxambi itself, choosing instead to focus all efforts on the Jardiance CV death claim and later let Glyxambi feed off Jardiance’s success. That made the new indication for Jardiance a matter of “need,” though, meaning Lilly’s execs are likely now breathing a sigh of relief.

Now, consensus estimates peg Jardiance as a $4 billion-or-so seller in 2025, Scotti noted, with that figure including Glyxambi’s contribution. About $1.7 billion of that haul will end up in Lilly’s pocket, he noted.