FDA panel to debate lucrative label change for Lilly's Jardiance

Eli Lilly

When Eli Lilly and Boehringer Ingelheim announced last year that their SGLT2 med, Jardiance, had become the first in that class of diabetes meds to show it could lower the risk of major cardiovascular events, the pharma world took notice. Now the companies will find out if the FDA will as well.

On Tuesday an FDA advisory panel is slated to vote on whether to recommend that the label for Jardiance be updated to reflect the findings. The FDA will then make its own decision on the question.

If the panel gives a thumbs up and the FDA follows suit, it will be a major boost for the drugmakers, handing their sales teams a major edge in selling against the competiton. It should help against Johnson & Johnson's ($JNJ) Invokana and AstraZeneca's ($AZN) Farxiga, which are in the same class, but which might also see some carry-over benefit themselves from a Jardiance label change. It would provide a big boost against meds in the DPP-4 class of diabetes meds, such as Merck's ($MRK) Januvia. 

Jardiance is already seeing significant growth and increased market share in the expanding SGLT2 class. Lilly reported that it raked in Jardiance revenues of $38.2 million in Q1, up 99%, with more than three-fourths of that, $29.7 million, coming from the U.S.

First reported last year, the data from a study of cardiac risks data showed Jardiance cut the combined risk of cardiac death, non-fatal heart attacks and non-fatal strokes by 14%. It cut the risk of death from any cause by 33%. However, there was no significant difference in the risk of non-fatal heart attack or non-fatal stroke, which could put some limits on what the drugmakers could claim.

One of the issues the FDA has asked the advisors to consider is whether the single trial provides “substantial evidence necessary to establish a new benefit.” FDA staff pointed out in its briefing document that usually more than one study is needed to make efficacy claims, but point out that there are situations “in which a single adequate and well-controlled study has served as the basis for a claim.”

That has led Leerink analyst Seamus Fernandez to tell clients to expect the FDA debate line to be drawn between what he termed "statistical purists" vs "clinicians," Reuters reports.

Lilly officials know what they will do if the FDA does approve a label update. They have said: “We will obviously put the right level of promotion behind that product, what we need to be successful.”

- here’s the FDA briefing document 
- here’s Boehringer Ingelheim’s briefing document 
- more from Reuters

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