Regulatory Decision Summary for Ozempic

The purpose of this submission is to seek market authorization for Ozempic, in a new drug product concentration of 0.68 mg/mL for the dual-dose (0.25 mg and 0.5 mg) PDS290 pre-filled, disposable, multi-dose pen-injector for adult patients with Type 2 diabetes mellitus who may benefit from additional glucose-lowering and body weight loss as the disease progresses. There are no proposed changes to the authorized indication, drug formulation, or dosing regimens.

Type 2 diabetes mellitus (T2DM) is a metabolic disorder of carbohydrate metabolism that is characterized by hyperglycemia over a prolonged period. It is associated with impairment in insulin (INS) secretion and peripheral resistance to the action of INS. Long-term complications from hyperglycemia include heart disease, stroke, and diabetic retinopathy, which can result in blindness, kidney failure, and poor blood flow in the limbs that may lead to amputations.

Authorization for the new drug product concentration of 0.68 mg/mL was based on 2 phase 1 studies:

• Trial 4649 was conducted as part of the Wegovy programme and was used to support bioequivalence between 0.68 mg/mL and 1.0 mg/mL semaglutide SC drug product concentrations at 0.25 mg dose administered using a PDS290 pen-injector.

• Trial 4387 was conducted as part of the Ozempic programme and was used to support bioequivalence between semaglutide SC formulations ((semaglutide B 1.34 mg/mL and semaglutide C (0.25 mg/mL, 0.5 mg/mL, and 2.0 mg/mL)).

In this Supplement to a New Drug Submission (SNDS), for cross trial comparison, only data for semaglutide B formulations and PDS290 semaglutide pen-injector arms were considered for both trials.

Ozempic and Wegovy are the same drugs, sold under different brand names. They are available in different strengths. Wegovy is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients, while Ozempic is indicated for the treatment of adult patients with type 2 diabetes mellitus to improve glycemic control in combination with diet and exercise.

The composition of the drug product with the new 0.68 mg/mL drug product concentration is identical to the marketed drug product; only the concentration of semaglutide varies along with an increased cartridge volume; the modified pen-injector variant has the identical functionality and user interface as the currently approved PDS290 semaglutide pen injectors.

Currently approved presentations are:

• One ‘dual-dose’ PDS290 semaglutide pen-injector supplying the 0.25 and 0.5 mg doses with a drug product concentration of 1.34 mg/mL semaglutide in 1.5 mL cartridges.

• One PDS290 semaglutide pen-injector supplying the 1 mg dose with a drug product concentration of 1.34 mg/mL semaglutide in 3 mL cartridges.

• One PDS290 semaglutide pen-injector supplying the 2 mg dose with a drug product concentration of 2.68 mg/mL semaglutide in 3 mL cartridges.

The final decision for the new product strength was based on totality of the evidence, including clinical comparison, pharmacokinetics, and modelling.

Overall, the benefit-risk profile for the new drug product concentration of 0.68 mg/mL was positive.

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