Last September, Eli Lilly ($LLY) and Boehringer Ingelheim made headlines when a big study showed their SGLT2 diabetes drug, Jardiance, could lower cardiovascular risks.
Now, the companies are one step closer to adding that study data to the drug's label--a win that could rock the marketplace, not only in the SGLT2 drug class, but in competitor categories like DPP-4 meds.
On Monday, the pair announced that the FDA had accepted a supplemental New Drug Application for Jardiance based on results from the 7,000-plus patient EMPA-REG study. In that study, Jardiance lowered the combined risk of heart attack, stroke and death from cardiovascular causes by 14% in high-risk Type 2 diabetes patients.
And that means the companies and their reps could start boasting about that CV benefit before the year is out.
As Evercore ISI analyst Mark Schoenebaum pointed out in September, opening the gate for reps could make a big impact. With a label change, reps would "be able to more easily speak … to the fact that if the doctors want to be intellectually honest and practice evidence-based medicine, they should really be prescribing Jardiance," he wrote in a note to clients.
Meanwhile, the data have already given Jardiance a boost over its SGLT2 brethren, Johnson & Johnson's ($JNJ) Invokana and AstraZeneca's ($AZN) Farxiga. As Lilly diabetes president Enrique Conterno told shareholders on a conference call earlier this month, Jardiance's new-to-brand share in the SGLT2 market recently jumped to 25% from 15%.
Don't feel too bad for J&J and AZ yet, though--or for other diabetes drug classes, for that matter. Several prominent payers--such as PBM giant CVS Health ($CVS)--have said that a label change in itself wouldn't prompt any new coverage on their end. They'll need an update to guidelines from bodies like the American Diabetes Association (ADA) before making it easier for patients to get their hands on the $4,800-per-year Jardiance.
Plus, until J&J and AZ complete their own CV outcomes studies--in 2017 and 2019, respectively--and potentially confirm a CV benefit for the entire SGLT2 class, their meds will be riding on Jardiance's coattails. On Tuesday's fourth-quarter conference call, J&J VP of investor relations Louise Mehrotra told investors that Invokana's U.S. market share had increased to 6.5% in Q4 from 6.3% in Q3.
- read the release
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