Fate of Lilly's Jardiance franchise rests on FDA's delayed heart-benefits indication

Eli Lilly hasn’t been shy about telling regulators and investors exactly what it wants--a new indication for Jardiance, the SGLT2 diabetes med it shares with Boehringer Ingelheim. But Jardiance isn't the only product depending on that potential FDA nod.

The company has switched up its promotional strategy for Glyxambi, a combo med that pairs the active ingredient in Jardiance, empagliflozin, with the DPP-4 product Tradjenta (linagliptin). The new approach? Forget investing in Glyxambi itself right now, company diabetes president Enrique Conterno told investors on Lilly’s Q3 conference call. Instead, the plan is to focus all efforts on snagging that new cardiovascular-friendly indication for Jardiance, and then let Glyxambi ride its success.

There’s just one potential problem with the Jardiance-first plan. As Conterno outlined, to make that franchise work, Lilly and BI “need” the new indication--which would deem Jardiance a preventive against cardiac death, based on impressive CV data from its outcomes trial announced last year.

That new use is crucial for Jardiance to solidify a standard-of-care position and “reinvigorate” critical growth in the SGLT2 class, which is currently expanding more slowly than Lilly had expected. But that indication isn’t necessarily a lock.

After a three-month decision date pushback, the FDA now says it’ll hand down a verdict on the new use by December 4. At least one analyst--Evercore ISI’s Mark Schoenebaum--has pegged Lilly’s probability of coming away victorious at “coin-flip odds,” despite a “yes” vote from an FDA advisory panel in June. That vote was split 12-11.

Of course, if the FDA doesn’t grant a new indication, that doesn’t mean Lilly and BI will go home empty-handed. If the agency decides to include favorable clinical data in the body of Jardiance’s label, “yes, we could still make a claim,” Conterno noted. The strength of that claim, though, “is not the same,” so the company views the indication “as important for us and for Jardiance and for Lilly and BI,” Conterno said.

Lilly’s Glyxambi blueprints got turned upside down last year when Jardiance showed it could cut the risk of CV death in high-risk Type 2 diabetes patients by a whopping 38%. After that, positioning Jardiance as a standard of care became priority No. 1, Conterno explained.

If Lilly can do that, Glyxambi will see a “very significant benefit,” Conterno predicted. But investing in the combo product right now “in a really big way ... really doesn’t make sense, whether it’s access or promotional investment,” he noted. (That access, by the way, is currently pretty dismal, with commercial coverage sitting at a percentage in the low 20s and Part D coverage “even lower.")

The indication will also be key for Jardiance as it looks to keep its footing against DPP-4 diabetes competitors, such as Merck’s Januvia. Safety issues have cropped up among SGLT2 patients, such as a risk of bone fractures and worries about decreased bone density associated with Johnson & Johnson’s Invokana. Bernstein analyst Tim Anderson recently wrote that those issues might be keeping class growth below expectations. DPP-4s, on the other hand? They have a “very clean safety profile,” and they’re no worse at lowering blood sugar, he noted--meaning Lilly and BI’s leg up over their rivals is the heart-helping data.

Meanwhile, Lilly reaped just $47.5 million in Jardiance sales for Q3, well below the $62 million analysts predicted.

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