The Food and Drug Administration has expanded the approval of Eli Lilly's (LLY 8.14%) Trulicity to include its use for the reduction of major adverse cardiovascular events in patients with type 2 diabetes who have established cardiovascular disease or multiple risk factors for developing cardiovascular issues.
The drug has been approved to treat patients with type 2 diabetes since 2014, but this label expansion makes Trulicity the first drug for type 2 diabetes approved for both preventing or managing risk factors and for reducing the risk of another event occurring.
The approval was based on the REWIND (Researching cardiovascular Events with a Weekly INcretin in Diabetes) study, which followed patients treated with Trulicity for a median of 5.4 years. The drug reduced the risk of major cardiovascular events such as heart attacks and strokes by 12%. The pharmaceutical company showed Trulicity worked equally well in patients with established cardiovascular disease as it did in patients who only had cardiovascular risk factors: a 13% reduction in events for both groups.
Trulicity is a GLP-1 receptor agonist, and has become the most-prescribed drug in its class, in large part because it only has to be injected once a week. But Eli Lilly's investors need to be looking in the over their shoulders at Novo Nordisk (NVO 3.27%), which gained FDA approval of an oral GLP-1 drug, Rybelsus, last year.
Rybelsus has some data on its label showing the drug might reduce cardiovascular events, but the patients in its studies were only followed for two years. Novo Nordisk sells the same active ingredient in Rybelsus as Ozempic, which needs to be injected, but it remains to be seen whether doctors will extrapolate the more robust cardiovascular events data from Ozempic to Rybelsus.