Back in November, news of a cardiovascular outcomes win for Trulicity pleased Eli Lilly investors who analysts called “skeptical.” Now, though, those same skeptics may be wondering just how well Trulicity’s performance can help it fend off new competition from Novo Nordisk.
Sunday at the American Diabetes Association annual meeting, the Indianapolis drugmaker unveiled data showing Trulicity had pared down the combined rate of heart attack, stroke and cardiovascular death by 12%. While Trulicity produced numerical benefits in each of those categories, they weren’t statistically significant.
Lilly’s numbers are likely lower than at least one analyst expected to see. “On efficacy hazard ratio, I doubt Lilly would have used the word ‘compelling’ without the HR being at least in the semaglutide-like range at least,” Evercore ISI’s Umer Raffat wrote after top-line results debuted.
As Lilly was quick to point out, though, its outcomes trial, dubbed Rewind, bore some key differences to Novo’s. For one, the majority of participants—about 69%—didn’t have already-established cardiovascular disease, a claim Lilly’s rivals can’t make.
Rewind also currently ranks as the class’ longest CV outcomes trial with an average follow-up of 5.4 years, and it enrolled a balanced ratio of women and men. And its benefits stayed consistent across various subgroups, Brad Woodward, Lilly’s global development leader for incretins, pointed out.
“We have a population that really is broad and representative of patients that are treated for Type 2 diabetes,” he said, adding that “we believe that effect is consistent across the groups and meaningful for patients who are being seen in physicians’ offices today.”
The pharma giant will be working to get the data on Trulicity’s label as quickly as possible, with semaglutide making its way toward the market to threaten market share. The company has already submitted Rewind in both the U.S. and Europe, and Lilly looks “forward to the regulatory review process,” Woodward said.
Meanwhile, though, it’s also working on a candidate that could shake up the GLP-1 market altogether. Also at ADA, Lilly added more positive data for tirzepatide, a GIP/GLP-1 dual receptor agonist that could spur the market to “bifurcate over time,” Bernstein analyst Wimal Kapadia wrote to clients earlier this month.
Kapadia models Lilly eventually taking “the larger share of the injectables and Novo outgrowing the broader GLP-1 market driven by oral sema.”
A Product Manager with expertise in pharma marketing and sales operations