Analysts and investors were less than amazed when Eli Lilly revealed cardiovascular outcomes data for its GLP-1 diabetes med Trulicity in late 2018. It wasn’t that the study didn’t hit its mark, they argued, but that the results weren’t impressive enough to move the needle in a competitive field.
But the data was impressive enough to score Trulicity a first-of-its-kind approval from the FDA, potentially putting analysts’ worries to rest.
The FDA on Friday approved Trulicity to reduce the risk of cardiovascular events in Type 2 diabetes patients with—or without—established CV disease, Lilly said in a release.
The approval marks a win for Lilly after results from Trulicity’s Rewind CV outcomes trial failed to win over skeptical analysts when top-line results came out in November 2018.
In that study, Trulicity cut the combined rate of heart attack, stroke and cardiovascular death by 12% over placebo. That data was enough to hit the study’s endpoint, but analysts weren’t impressed––particularly in light of Novo Nordisk’s GLP-1 competitor Ozempic having shown a 26% risk reduction in its own trial back in 2016.
“We believe investors may have been hoping for a greater risk reduction,” Credit Suisse analyst Vamil Divan told clients in June, with Bernstein’s Wimal Kapadia adding that, “Trulicity delivered but it underwhelmed.”
Of course, the big difference between Trulicity’s and Ozempic’s studies was that 69% of Rewind trial patients didn’t have an established CV disease, putting the drug on track to score its first-of-a-kind approval last week.
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With a much broader label, Trulicity is well-positioned to boost the $4.13 billion in sales it posted during 2019, but analysts doubt any growth will hurt Ozempic.
For one, primary-care physicians prescribing GLP-1 meds are “often less data-driven,” Divan noted, and are instead more interested in access to reimbursement and easier applications like autoinjectors. Moreover, the CV label win for Trulicity could become a win for the GLP-1 market on the whole.
“Physicians will see a broad CV claim as a class effect,” Kapadia wrote in June. “In short, we expect Trulicity to benefit but not at the expense of Ozempic.”
Any lift is welcome for Lilly, though, after Ozempic scored its own heart-helping nod in January, receiving an FDA green light to treat patients with Type 2 diabetes and established CV disease. Trulicity is also now competing again Rybelsus, a once-daily tablet that shares Ozempic’s active ingredient.
Ozempic, initially approved in December 2017, launched in early 2018 and has since raced out to blockbuster status. In the first nine months of 2019, Ozempic posted DKK 11.24 billion ($1.63 billion) in global sales.
