Regulatory Decision Summary for Dupixent

The purpose of this Supplement to a New Drug Submission (SNDS) was to obtain market authorization, pursuant to section C.08.004 of the Food and Drugs Regulations, for Dupixent, filed by Sanofi-Aventis Canada Inc. for the following new indication:

As an add-on maintenance treatment in adult patients with uncontrolled chronic obstructive pulmonary disease (COPD) associated with type 2 inflammation.

Upon review of the submitted data package, Health Canada authorized Dupixent for the following indication:

Add-on maintenance treatment in adult patients with chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils inadequately controlled by the combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.

The benefit of Dupixent in chronic obstructive pulmonary disease (COPD) was primarily demonstrated by two randomized, double-blind, multicenter, parallel-group, placebo-controlled trials (BOREAS and NOTUS) of 52 weeks in treatment duration which enrolled a total of 1874 patients to evaluate Dupixent as an add-on maintenance therapy for COPD. In both trials, patients were randomized to receive Dupixent 300 mg every two weeks (Q2W) or placebo in addition to their background maintenance therapy for 52 weeks.

In both trials (BOREAS and NOTUS), Dupixent demonstrated a statistically significant reduction of 30% in the rate of moderate or severe COPD exacerbations compared to placebo when added to background maintenance therapy. Reductions in the annualized rate of moderate or severe exacerbations were similarly observed across all predefined subgroups. Dupixent also demonstrated a statistically significant improvement in pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) at Weeks 12 and 52 compared to placebo when added to background maintenance therapy. As well, the responder rate (defined as the proportion of subjects with St. George's Respiratory Questionnaire (SGRQ) improvement from baseline of at least 4 points) was significantly greater for patients treated with Dupixent (51%) compared to placebo (43%) in BOREAS.

Dupixent was well tolerated in subjects receiving treatment for up to 52 weeks. The proportion of patients who discontinued treatment due to adverse events was 3% of the placebo group and 3% of the Dupixent 300 mg Q2W group. There was no pronounced trend toward an increased risk of any adverse reaction between dupilumab and placebo.

An updated Risk Management Plan (RMP) for Dupixent was reviewed by Health Canada and considered acceptable.

The final labelling and Product Monograph were considered acceptable.

Overall, the benefit-risk profile was favourable for Dupixent for the approved indication when used under the conditions of use recommended in the approved Product Monograph. Therefore, a Notice of Compliance (NOC) was recommended.

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