Tapinarof cream 1%
Trade Name: Nduvra™
Company: Organon Canada
Approval Dates/Comments: In April 2025, Health Canada approved this aryl hydrocarbon receptor (AhR) agonist indicated for the once-daily, topical treatment of adults with plaque psoriasis. The mechanism of action of tapinarof involves binding to AhR, a protein implicated in regulating immune responses and skin barrier functions, which leads to suppression of inflammatory cytokines (such as IL-17 and IL-22), reduction of oxidative stress, and modulation of skin barrier protein expression. These combined effects contribute to improved skin function and reduced inflammation. Tapinarof is a non-steroidal agent suitable for long-term use, both as monotherapy or in combination with systemic therapies. Apart from hypersensitivity reactions, there are no known contraindications. Regulatory approval was based on findings from two identical Phase 3 trials (PSOARING 1 and PSOARING 2), which demonstrated statistically significant improvement in Physician Global Assessment (PGA) score of “clear” (PGA=0) or “almost clear” (PGA=1) with a minimum 2-grade improvement vs. vehicle from baseline at week 12. Tapinarof also showed significant improvement in all secondary endpoints vs. vehicle, including ≥75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline at week 12. The majority of adverse effects were mild to moderate and localized to the application site, with the most common being folliculitis, nasopharyngitis, and contact dermatitis. Eligible patients who completed PSOARING 1 or PSOARING 2 were enrolled in PSOARING 3, a Phase 3 Long Term Extension (LTE) study that extended openlabel tapinarof treatment by an additional 40 weeks. In total, patients who received tapinarof in PSOARING 1 or PSOARING 2 and also completed the LTE study received treatment for up to 52 weeks. More than 40% of LTE study patients (n=312/763) achieved complete clearance (PGA=0) at least once. Safety and tolerability were consistent in all three trials. Tapinarof is currently under review by Health Canada for an additional indication to treat atopic dermatitis (AD) in patients ≥2 years of age. In the US, initial FDA approval of tapinarof (Vtama®) was granted in May 2022 for plaque psoriasis, followed by an expanded label to treat AD for patients aged ≥2 years in December 2024.
Omalizumab-igec for SC injection
Trade Name: Omlyclo®
Company: Celltrion
Approval Dates/Comments: In March 2025, the US FDA approved the first and only biosimilar designated as interchangeable with Xolair® (omalizumab) for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, immunoglobulin E-mediated food allergy, and chronic spontaneous urticaria.
Retifanlimab for IV infusion
Trade Name: Zynyz®
Company: Incyte Corporation
Approval Dates/Comments: Health Canada approved this programmed cell death 1 (PD-1)–blocking antibody in February 2025 for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma not amenable to curative surgery or radiation therapy. This humanized monoclonal antibody specifically targets and binds to PD-1, preventing its interaction with its ligands, PD-L1 and PD-L2. This blockade reactivates T cells, promoting a more robust immune response against cancer cells.
