BRIEF—Dupixent gains Canadian approval for CRSwNP

Health Canada has approved a new indication for Sanofi and Regeneron’s Dupixent (dupilumab injection), as an add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyposis (CRSwNP) inadequately controlled by systemic corticosteroids and/or surgery, making it the first biologic for the treatment of this disease in Canada.

Dupixent is already one of Sanofi’s top selling products, generating global revenues of 858 million euros ($1.01 billion) in the second quarter of this year.

The Health Canada approval is based on two pivotal Phase III trials (the 24-week SINUS-24 and 52-week SINUS-52) that evaluated Dupixent 300mg every two weeks plus standard-of-care intranasal corticosteroids compared to placebo plus intranasal corticosteroids.

In these trials, patients treated with Dupixent achieved statistically-significant improvements in all primary and secondary endpoints at 24 weeks.

Dupixent was first approved by Health Canada on November 30, 2017 and remains the only biologic medicine for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

In September 2019, Health Canada expanded the approval to include adolescents aged 12 years and older.