Roflumilast cream 0.3%

Trade Name: Zoryve
Company: Arcutis Biotherapeutics

Approval Dates/Comments: The US FDA approved roflumilast, the first and only topical phosphodiesterase-4 (PDE4) inhibitor, cream 0.3% in July 2022 for the treatment of plaque psoriasis, including intertriginous areas, in patients ≥12 years of age. Approval of this once-daily, steroid-free cream was based on data from the Phase 3 DERMIS-1 (NCT04211363) and DERMIS-2 (NCT04211389) trials, which compared the efficacy and safety of roflumilast cream to vehicle in 881 patients with mild to severe plaque psoriasis and an affected body surface area of 2%-20%. Findings from both trials demonstrated a greater proportion of patients treated with roflumilast cream vs. vehicle met the primary endpoint, achieving Investigator Global Assessment treatment success at week 8, defined as a score of “clear” or “almost clear” with a 2-grade improvement from baseline.

Ruxolitinib cream 1.5%

Trade Name: Opzelura
Company: Incyte Corporation

Approval Dates/Comments: In July 2022, the FDA approved ruxolitinib cream 1.5%, the first and only topical therapy for repigmentation in nonsegmental vitiligo in adults and children ≥12 years. Approval was based on results from the pivotal Phase 3 TRuE-V clinical trials (TRuE-V1 and TRuE-V2), which assessed the safety and efficacy of ruxolitinib vs. vehicle in >600 subjects with nonsegmental vitiligo – treatment resulted in significant improvements in Vitiligo Area Severity Index (VASI) scores. The drug is already approved for topical short-term and non-continuous treatment of mild to moderate atopic dermatitis in non-immunocompromised patients ≥12 years of age.

HA-based dermal filler

Trade Name: Juvéderm® Volux™ XC
Company: Allergan Aesthetics

Approval Dates/Comments: In July 2022, the FDA approved this hyaluronic acid (HA)-based gel implant indicated for subcutaneous and/or supraperiosteal injection for improvement of jawline definition in adults aged >21 years with moderate to severe loss of jawline definition.

Abrocitinib tablets

Trade Name: Cinbinqo®
Company: Pfizer Canada

Approval Dates/Comments: Health Canada approved abrocitinib, a Janus kinase 1 inhibitor, in June 2022 as an oral, once-daily treatment of patients aged ≥12 years with refractory moderate to severe atopic dermatitis, including the relief of pruritus, who have had an inadequate response to other systemic drugs (e.g., steroid or biologic), or for whom these treatments are not advisable.

LetibotulinumtoxinA for injection

Trade Name: Letybo®
Company: Croma Aesthetics

Approval Dates/Comments: Market authorization was granted by Health Canada in June 2022 for this injectable formulation of botulinum toxin A for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults <65 years of age.

Berotralstat capsules

Trade Name: Orladeyo®
Company: BioCryst

Approval Dates/Comments: In June 2022, Health Canada approved once-daily, oral berotralstat, a plasma kallikrein inhibitor, indicated for prophylaxis to prevent hereditary angioedema attacks in patients ≥12 years of age.

Mogamulizumab IV infusion

Trade Name: Poteligeo®
Company: Kyowa Kirin

Approval Dates/Comments: In June 2022, Health Canada approved this humanized monoclonal antibody directed against CC chemokine receptor 4 for treating adults with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy

Avacopan capsules

Trade Name: Tavneos®
Company: Otsuka Canada

Approval Dates/Comments: Health Canada approved avacopan, an orally administered selective complement 5a receptor inhibitor in April 2022, for the adjunctive treatment of adults with severe active antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis), in combination with standard background therapy including glucocorticoids.

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