Regulatory Decision Summary for Ozempic

Decision issued

No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.

Date of cancellation

March 06, 2020

What was the purpose of this submission?

The purpose of this submission was to propose the following indication: "Ozempic is indicated to reduce the risk of major cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes and established cardiovascular disease and/or chronic kidney disease."

What did the company submit to support its submission?

The sponsor submitted non-clinical and clinical data. The clinical safety and efficacy information consisted of the following: a Phase 3 clinical trial (PIONEER 6) of oral semaglutide and a pooled analysis that combined the primary endpoint results of PIONEER 6 with the primary endpoint results of the Phase 3 clinical trial SUSTAIN 6 (subcutaneous semaglutide). The SUSTAIN 6 study was evaluated by Health Canada in a previous Ozempic submission.

PIONEER 6 was a double-blind clinical trial in which orally administered semaglutide or placebo were added to and used concomitantly with standard of care treatments in 3,183 patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease. The primary endpoint was the time to first major adverse cardiovascular event (MACE) defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.

SUSTAIN 6 was a double-blind clinical trial in which subcutaneously administered semaglutide or placebo were added to and used concomitantly with standard of care treatments in 3,297 patients with Type 2 diabetes mellitus and atherosclerotic cardiovascular disease. As in the PIONEER 6 study, the primary endpoint was the time to first major adverse cardiovascular event (MACE). The pooled analysis combined the time to first MACE results from PIONEER 6 with the time to first MACE results from SUSTAIN 6.

What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?

At the time of the cancellation, the review of the submission was nearing completion. Health Canada had identified deficiencies in the data that would have precluded issuing an approval. The sponsor chose to cancel the submission and may re-file at a later date with additional data.

What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?

There is no expected impact for patients using SAP or in clinical trials. Ozempic remains authorized for sale in Canada.