Ruxolitinib phosphate cream 1.5%
Trade Name: Opzelura®
Company: Incyte Biosciences
Approval Dates/Comments: In October 2024, Health Canada approved ruxolitinib cream 1.5%, a non-steroidal topical Janus kinase (JAK) inhibitor, for the treatment of mild to moderate atopic dermatitis in patients ≥12 years of age whose disease is not adequately controlled with conventional topical prescription therapies (i.e., topical corticosteroids and topical calcineurin inhibitors) or when those therapies are inadvisable. Additionally, Health Canada approved a second indication for ruxolitinib to treat nonsegmental vitiligo in adult and pediatric patients ≥12 years of age.
Roflumilast foam 0.3%
Trade Name: Zoryve®
Company: Arcutis Canada
Approval Dates/Comments: In October 2024, Health Canada approved this novel, steroid-free, once-daily phosphodiesterase-4 (PDE4) inhibitor for the topical treatment of seborrheic dermatitis in patients ≥9 years of age.
Clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% fixed-dose topical gel
Trade Name: Cabtreo™
Company: Bausch Health
Approval Dates/Comments: In September 2024, Health Canada approved this novel, fixed-dose triple-combination (clindamycin phosphate, adapalene and benzoyl peroxide) topical gel indicated for the treatment of acne vulgaris in patients ≥12 years of age. This first and only three-ingredient acne product is administered once-daily and offers separate mechanisms of action by combining antibiotic, retinoid and antibacterial agents to target multiple pathogenic factors.
Lebrikizumab-lbkz
Trade Name: Ebglyss™ SC injection
Company: Eli Lilly
Approval Dates/Comments: The US FDA approved this interleukin (IL)-13 antagonist in September 2024 for the treatment of adults and children ≥12 years of age who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis that is not well controlled despite treatment with topical prescription therapies. This regulatory decision was based on results from ADvocate 1, ADvocate 2, and ADhere studies. ADvocate 1 and ADvocate 2 studies demonstrated that 38% of patients receiving lebrikizumab achieved clear or almost-clear skin at 16 weeks vs. 12% with placebo, and 10% experienced improvement as early as 4 weeks. Health Canada approval was granted in June 2024.
Ustekinumab-srlf
Trade Name: Imuldosa™ SC/IV injection
Company: Accord BioPharma
Intas Pharmaceuticals
Approval Dates/Comments: In October 2024, the FDA approved this human IL-12/IL-23 antagonist as a biosimilar to Stelara® (Janssen) for all indications of its reference drug, including the treatment of moderate-to-severe plaque psoriasis in patients ≥6 years of age who are candidates for phototherapy or systemic therapy and active psoriatic arthritis in patients aged ≥6 years.
Ustekinumab-aauz
Trade Name: Otulfi™ SC/IV injection
Company: Fresenius Kabi
Approval Dates/Comments: The FDA approved this IL-12/IL-23 monoclonal antibody referencing Stelara® in September 2024. Approved indications include moderate-to-severe plaque psoriasis in patients ≥6 years of age who are candidates for phototherapy or systemic therapy and patients ≥6 years of age with active psoriatic arthritis.
Ustekinumab biosimilar
Trade Name: Pyzchiva™ SC/IV injection
Company: Samsung Bioepis (commercialized by Sandoz in Canada)
Approval Dates/Comments: In August 2024, Health Canada approved Pyzchiva™, a biosimilar to the originator drug Stelara®, for the same indications including the treatment of adult patients with chronic moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy and adult patients with active psoriatic arthritis. Health Canada has not authorized an indication for pediatric use.
