Novo Nordisk’s Ozempic (semaglutide) Receives the US FDA’s Approval for Reduction in MACE in Patients with Type 2 Diabetes

Novo Nordisk’s Ozempic (semaglutide) Receives the US FDA’s Approval for Reduction in MACE in Patients with Type 2 Diabetes

Shots:

  • The approval is based on SUSTAIN 6 CVOT study assessing Ozempic (0.5mg /1mg, inj.) vs PBO + SOC in 3297 patients with T2D with established CVDs
  • The SUSTAIN 6 study results: @2yrs. 26% reduction in risk of MACE; primary composite outcome (6.6% vs 8.9%)
  • Additionally, Rybelsus (semaglutide, 7mg/14mg) prescribing information has been updated in section 14 (clinical studies) to include an analysis from 1EPs of the PIONEER 6 CVOT study demonstrating the hazard ratio for time to first three-component MACE

Click here ­to­ read full press release/ article | Ref: Novo Nordisk | Image: The Pharma Letter