Boehringer Ingelheim and Eli Lilly’s Tradjenta is working to pick up share in an ultracompetitive diabetes market, and it’s hoping some new outcomes data can help it do exactly that.
On Thursday at the European Association for the Study of Diabetes Annual Meeting, the pair rolled out data from a long-term study showing that Tradjenta performed similarly to placebo in the cardiovascular safety department. Specifically, heart attack, stroke and cardiovascular death occurred in 12.4% of the Tradjenta group, compared with 12.1% of the placebo group.
And that safety profile held true in diabetic adults who also had kidney disease, the companies said.
The results “reinforce confidence in Tradjenta as an effective and well-tolerated treatment and are particularly meaningful for those most vulnerable to serious complications, including heart failure and kidney disease,” Boehringer’s SVP of medicine and regulatory affairs, Thomas Seck, M.D., said in a statement.
The showing is an important one for Tradjenta, which is up against heavyweight DPP-4 competitor Januvia from Merck & Co. That blockbuster showed back in 2015, as part of the closely watched TECOS trial, that it didn’t hurt heart health.
But the big question diabetes drugmakers face these days is whether just showing heart safety is enough. The Boehringer-Lilly team was the first to show that diabetes drugs could actually improve CV outcomes for patients; its SGLT2 drug, Jardiance posted a 38% reduction in cardiovascular death in an outcomes study of its own, and that data went on to grace its label thanks to a December 2016 thumbs up from the FDA.
Since then, its SGLT2 rivals and drugs from the GLP-1 class—including Novo Nordisk's Victoza and follow-up med Ozempic—have gone on to show they could improve CV outcomes too, upstaging their DPP-4 brethren. But drugmakers competing in the category have long suggested that physicians need an array of options for battling the tough disease—including theirs.
"Diabetes is a complex condition to manage and there remains a need for treatments with proven long-term cardiovascular and renal outcomes," Seck said.