Novo's Ozempic scores major win with heart-helping FDA approval. Is Rybelsus next?

After racing out to a fast start in its first year on the market, Novo Nordisk's GLP-1 diabetes superstar Ozempic is already proving a darling for the Danish drugmaker. Now, a heart-helping FDA approval will likely spell even more success for the standout––and bodes well for Novo's other much-touted diabetes launch.

The FDA approved Ozempic to reduce the risk of cardiovascular events in patients with Type 2 diabetes and an established cardiovascular disease, the company said Thursday.

The administration based its decision on Novo's cardiovascular outcomes study, dubbed Sustain 6, that showed patients treated with Ozempic posted a 26% relative risk reduction over placebo in preventing CV events, including death, non-fatal heart attacks and non-fatal strokes. 

Ozempic, initially approved in December 2017 as a treatment for diabetes, launched in early 2018 and has since raced out to blockbuster status. In the first nine months of 2019, Ozempic posted DKK 6.87 billion ($1 billion) in global sales. 

"Today's milestone establishes Ozempic as an option for patients to help address two critical aspects of managing type 2 diabetes, blood sugar control and cardiovascular risk reduction, in those with known heart disease," said Todd Hobbs, Novo VP and U.S. chief medical officer. 

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