Eli Lilly's Trulicity nabs novel CV approval in patients with or without established disease

Eli Lilly's Trulicity is in a heated battle with Novo's Ozempic for supremacy in the GLP-1 market. (Eli Lilly)

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. 

RELATED: ADA: Lilly's Trulicity cuts heart risks by 12%. Is it enough to fend off Novo's semaglutide?