- Eli Lilly and German drugmaker Boehringer Ingelheim notched a major regulatory win Friday, securing approval from the Food and Drug Administration of an expanded indication for the diabetes drug Jardiance (empagliflozin).
- The companies can now market Jardiance as reducing the risk of cardiovascular death in adult patients with type 2 diabetes and cardiovascular (CV) disease — an important competitive advantage which Lilly hopes will jumpstart sales.
- A landmark study known as EMPA-REG showed treatment with Jardiance reduced the risk of CV events such as heart attack and stroke by 14% and CV-related deaths by 38%. Cardiovascular events such as these are a leading cause of death for type 2 diabetes patients.
Even with the positive EMPA-REG data, an expanded label for Jardiance was not guaranteed.
An advisory panel to the FDA in June narrowly recommended allowing the two companies to make the CV claim, sparking doubts the FDA would approve the new label. A decision had been expected sooner but the FDA decided to extend its review period by three months to Dec. 4. The agency often issues a decision early when action dates fall on the weekend.
Lilly and Boehringer had requested a distinct CV indication for Jardiance, which had up until now only been approved as an addition to diet and exercise to improve glycemic control for type 2 diabetes patients. The FDA's decision Friday therefore secures the drugmakers' hoped-for changes to Jardiance's label and make it the first diabetes drug to be able to make such claims.
To date, Lilly has seen slower-than-expected growth from the SGLT-2 inhibitor and has had trouble competing with the class leader, Johnson & Johnson's Invokana (canagliflozin), which was also first to market. The Indianapolis-based drugmaker hopes a new label will buoy class growth, driving up sales of Jardiance at the same time.
"We are hopeful that the inclusion of the empiric outcome data on the label will be a catalyst for the overall growth," Enrique Conterno, head of Lilly Diabetes, said on a third quarter earnings call in October.
The expanded label could also deliver a boost to Lilly and Boehringer's combo diabetes drug Glyxambi, which adds the DPP-4 drug Trajenta (linagliptin) to Jardiance.
Under a diabetes collaboration, Lilly and Boehringer co-market several drugs across 17 countries, sharing costs and revenues. Lilly records revenue from Jardiance, which totaled just over $125 million this year through September, under collaboration and other revenues in its financial reports.