UPDATED: Lilly, BI narrowly escape with panel backing for Jardiance CV death claim


Eli Lilly and Boehringer Ingelheim got the verdict they were looking for Tuesday, when an FDA advisory panel backed their claim that the SGLT2 diabetes contender, Jardiance, cuts the risk of cardiovascular death. But the vote was closer than the pair would have liked.

The drugmakers came away with the experts’ favor by a narrow 12-11 vote, and now it’ll be up to the FDA itself to decide whether to follow their recommendation. While the agency is not obligated to take their advice, it usually does.

Lilly and BI have been crossing their fingers for a “yes” vote ever since last year, when Jardiance became the first diabetes drug to show it could cut the combined risk of heart attack, stroke and cardiovascular death--which it did by 14%. But it pared down the risk of cardiovascular death on its own even more dramatically, reducing it by 38%.

If the companies do get their wish, they expect to see an “inflection point” in sales, Lilly diabetes chief Enrique Conterno has told investors. Sales reps will have a green light to trumpet the data, which the companies generated through their EMPA-REG outcomes study. And “we will obviously put the right level of promotion behind that product,” Lilly execs said last week on a call with investors.

Jardiance's SGLT2 rivals may see a boost, too, if docs assume a class-wide effect for the meds--even though it'll be a little while before their makers have their own outcomes data in hand. Johnson & Johnson doesn't expect to have results from its Invokana study until next year, while AstraZeneca will have to wait until 2019 to see whether its Farxiga can provide a similar benefit.

But advisory committee panelists expressed some concerns Tuesday that echoed those expressed by the FDA itself in premeeting briefing documents. For one, EMPA-REG is a single study initially designed to assess safety outcomes, and “the FDA has asserted that two confirmatory studies are typically required” to widen a label, Evercore ISI analyst Mark Schoenebaum wrote in a midday note to clients Tuesday.

Regulators also asked committee members to consider the 124 nonassessable deaths that occurred during the study; as the FDA wrote in its briefing documents, those could have altered the study’s results.

Bernstein analyst Tim Anderson, though, expects the FDA to give Lilly and BI the go-ahead. "In this instance, granting Jardiance a CV mortality claim does not mean that prescribers stop using other diabetes drugs that have a proven CV benefit, because no diabetes drugs have ever proven such a benefit," he wrote in a note Tuesday evening. "Rather, current diabetes drugs are all approved based on their ability to lower blood sugar, which is what SGLT2s, like Jardiance, do too."  

Schoenebaum, on the other hand, isn't so sure. "Despite the slight overall majority of votes in favor of the new CV indication, we view approval for an actual CV death indication as having coin-flip odds given the unprecedented nature/results of the trial," he wrote to clients Wednesday. 

But in his view, that wouldn't be the end of the world for the drugmakers. Longer term, the label claim may not matter, he wrote, "as long as data are described."

Meanwhile, Jardiance is no longer the only drug that's shown it can cut down on CV risks; it's now joined by Novo Nordisk's Victoza, a GLP-1 competitor, which announced it had accomplished the feat earlier this year. Some analysts, though, deemed Novo's results lackluster in comparison with Jardiance's: Victoza took a 13% bite out of the combined risk of heart attack, stroke and death from cardiovascular causes, while delivering a 22% lower risk of cardiovascular death.

- read the release 

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