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.