Lilly's Jardiance gets a boost as ADA tweaks its treatment guidelines

Eli Lilly expects Jardiance sales to spike now that the American Diabetes Association has tweaked its guidelines to back the drug.

Eli Lilly and Boehringer Ingelheim’s reps aren’t the only ones pushing for use of the drugmakers’ SGLT2 diabetes med Jardiance anymore. The American Diabetes Association has recommended the med in its official guidelines for 2017.

The ADA gave the product a shoutout in its 2017 Standards of Medical Care in Diabetes, backing it to reduce the risk of cardiovascular death in Type 2 patients with established cardiovascular disease. That recommendation comes on the back of an outcomes trial that last year showed Jardiance could pare down CV death risk by 38%.

As Barclays analyst Geoff Meacham wrote in a note to clients, the recommendation “received a B-level assessment in terms of strength of the evidence, which may reflect the ADA’s views on the various cardiovascular endpoint components” in the companies’ outcomes trial.

Nevertheless, though, he views the recommendation “as a positive” for the companies—and Lilly’s diabetes head Enrique Conterno agrees. He’s told investors repeatedly that he expected an ADA guideline switch to provide one of two upcoming “inflection points” in the product’s sales.

The other? A new FDA indication for preventing CV death, which the product snagged earlier this month. Now that the Indianapolis pharma giant has that green light, it’s planning for a sales spike that it expects “to be immediate upon starting promotion” in January, Conterno told investors on a conference call last week. And Meacham estimates the product could hit $3 billion in peak sales with the CV label claim in Lilly’s back pocket.

Meanwhile, Jardiance’s market share is already on the rise within the SGLT2 class, he pointed out. For the week ended Dec. 9, it logged new prescription share of 22.1% and total prescription share of 21.1%. The ADA recommendation might give the product another boost; it warned that whether “other SGLT2 inhibitors will have the same effect in high-risk patients … remains unknown.”

That wording may negate some of the “class effect” Jardiance’s rivals have been enjoying since its outcomes data hit late last year. While Johnson & Johnson, which makes Invokana, and AstraZeneca, the manufacturer of Farxiga, won’t wrap up their respective outcomes trials until 2017 and 2019, respectively, they’ve managed to piggyback on some of Jardiance’s success under the assumption that they’ll turn up similar results.

And if Invokana does? “We think the SGLT2 class could approximate the current ~$7 billion DPP-4 class in terms of market size,” Meacham wrote.