Ozempic receives expanded approval from FDA

The FDA has approved Novo Nordisk’s Ozempic—once-weekly semaglutide—for an expanded indication of CV risk reduction in people with type 2 diabetes and established heart disease.

The label expansion was based on a supplemental New Drug Application for Ozempic for reducing the risk of major adverse cardiovascular events including CV death, nonfatal MI and nonfatal stroke in adults with both T2D and CVD, Novo Nordisk said in a statement released Jan. 16. Approval was rooted in the success of the SUSTAIN 6 cardiovascular outcomes trial (CVOT), which found that Ozempic reduced the risk of CV death, nonfatal MI and nonfatal stroke by 26% when added to standard therapy compared to a placebo drug.

“We strongly believe in the benefits of semaglutide, and this approval marks an important milestone,” Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said in the company’s statement. “Ozempic now offers people in the U.S. with type 2 diabetes and established cardiovascular disease an effective treatment option to both lower their blood glucose and reduce their cardiovascular risk.”

In addition to expanded Ozempic approvals, the FDA also updated the label for Novo Nordisk’s Rybelsus—another formulation of semaglutide. The updated label includes additional information about the CV safety of Rybelsus as demonstrated in the PIONEER 6 CVOT. 

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