FDA Expands Labels for 2 Semaglutide Medications

Officials with the FDA have approved a label expansion for Novo Nordisk’s once-weekly semaglutide (Ozempic). The medication is newly indication for reducing the risk of major adverse cardiovascular events (MACE) including cardiovascular death, nonfatal heart attack, or nonfatal stroke in adults with type 2 diabetes and established cardiovascular disease (CVD).

The approval is based on the SUSTAIN 6 cardiovascular outcomes trial (CVOT), which demonstrated that once-weekly semaglutide statistically significantly reduced the risk of CV death, nonfatal heart attack or nonfatal stroke by 26% versus placebo, when added to standard of care in people with type 2 diabetes with increased CV risk, according to Novo Nordisk.

Once-weekly semaglutide is an analogue of the naturally occurring hormone glucagon-like peptide-1 (GLP-1). It is administered with injection of 0.5 mg or 1 mg, and indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes as well as to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease. The medication was first approved by the FDA in 2017.

The company also announced the FDA’s approval of an updated label for the Novo Nordisk’s oral semaglutide (Rybelsus) to include additional information from the PIONEER 6 CVOT demonstrating CV safety. Oral semaglutide demonstrated CV safety by meeting the primary endpoint of noninferiority for the composite MACE endpoint. The proportion of patients who experienced at least one MACE was 3.8% with Rybelsus^® and 4.8% with placebo.

Oral semaglutide is the world’s first and only GLP-1 in a tablet. It is administered once daily, and is approved for use in 2 therapeutic dosages, 7 mg and 14 mg.

Novo Nordisk’s oral semaglutide tablet was approved by the FDA in September 2019.

REFERENCE

Rybelsus® label updated with additional information from the PIONEER 6 CV outcomes trial [news release]. Bagsværd, Denmark; January 16, 2020: Novo Nordisk [email]. Accessed January 17, 2020.