Regulatory Decision Summary for Ozempic

This Supplement to a New Drug Submission (SNDS) - Clinical only was filed with the purpose of expanding the indication for Ozempic to include the reduction of the risk of certain negative health outcomes in patients with Type 2 diabetes (T2D) and chronic kidney disease (CKD).

A total of 3,533 patients with T2D and CKD were randomised 1:1 in the FLOW trial to subcutaneous Ozempic 1 mg (N = 1,767) or placebo (N = 1,766) once weekly in addition to standard of care and were followed for a median time of 40.9 months. The renal protective benefits of Ozempic were demonstrated, including a lower relative risk of the primary composite kidney events and a lower annual rate of decline in estimated glomerular filtration rate (eGFR). With the exception of renal death, all other individual components of the primary composite outcome (reduction in a sustained decline in eGFR, progression to kidney failure and cardiovascular (CV) death) contributed to the treatment effect of Ozempic over placebo.

The superiority of Ozempic to placebo was also demonstrated for the confirmatory secondary endpoints of reduction in the annual rate of change in eGFR (chronic kidney disease epidemiology collaboration [CKD-EPI]; total eGFR slope) and in the incidence of all-cause death. For the 3-point composite major adverse cardiovascular events (MACE) endpoint, the treatment effect was primarily driven by CV death and non-fatal myocardial infarction (MI), but not by non-fatal stroke.

The effects of Ozempic on the primary composite endpoint and secondary endpoints were consistent across prespecified subpopulations defined by demographics and baseline characteristics, kidney function, CV history, and selected concomitant standard of care medications at baseline. While power was limited due to the small number of patients on sodium-glucose cotransporter 2 (SGLT2) inhibitors at baseline, no clear heterogeneity by SGLT2 inhibitor use was observed for the primary or confirmatory secondary outcomes.

Safety data collected in the FLOW trial focused on serious adverse events (SAEs) and selected predefined categories of adverse events (AEs) regardless of seriousness. The safety profile of Ozempic in patients with Type 2 diabetes (T2D) and CKD was in line with that observed in previous trials with semaglutide as well as other well-characterised glucagon-like peptide-1 receptor agonists (GLP-1 RAs). No new serious or severe adverse reactions were identified in this trial.

The benefit-risk-uncertainty assessment of Ozempic is considered favourable for the treatment of adults with T2D and CKD when used under the conditions of use recommended in the approved Product Monograph. Therefore, a Notice of Compliance (NOC) was recommended.

The labelling information submitted met all applicable regulations and guidance.

For further details about Ozempic, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.