Icotrokinra 200 mg tablet
Trade Name: Icotyde™
Company: Johnson & Johnson
Approval Dates/Comments: In March 2026, the US FDA approved this first-in-class, interleukin-23 (IL-23) receptor antagonist for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients ≥12 years of age weighing at least 40 kg who are candidates for systemic therapy or phototherapy. Approval of this once-daily, oral peptide was based on findings from four Phase 3 trials involving 2500 patients (ICONIC-ADVANCE 1, 2, LEAD, and TOTAL), which demonstrated high rates of skin clearance and a favorable safety profile compared with placebo and deucravacitinib. In head-to-head superiority studies, about 70% of patients treated with icotrokinra achieved Investigator’s Global Assessment 0/1 (clear or almost clear skin), and 55% of patients achieved a Psoriasis Area and Severity Index 90 response at week 16 vs. deucravacitinib. Through week 16, rates of adverse reactions in patients treated with icotrokinra were within 1.1% of placebo through week 16, with no new safety signals identified through week 52. Further data from the ICONIC-LEAD trial, the first study to evaluate systemic therapy in both adolescents and adults with moderate-to-severe plaque psoriasis, showed that nearly half of patients reached completely clear skin by week 24. Recently reported 1-year results confirm durable skin clearance and a favorable safety profile in adolescents through week 52.
Difamilast 1% ointment
Trade Name: Adquey™
Company: Acrotech/Otsuka
Approval Dates/Comments: The FDA approved difamilast in February 2026 for the twice-daily topical treatment of mild-to-moderate atopic dermatitis (AD) in adults and children aged ≥2 years. This novel, non-steroidal, small molecule phosphodiesterase 4 (PDE4) inhibitor has antipruritic and anti-inflammatory properties with a rapid onset of action. In Phase 3 controlled trials, a significantly higher percentage of patients treated with difamilast achieved Investigator’s Global Assessment (IGA) success (defined as clear or almost clear skin with ≥2-point improvement) after 4 weeks of therapy. Week 4 IGA success for the trial in adult patients was 38.46% with difamilast 1% vs. 12.64% with vehicle (P<0.0001). For the pediatric Phase 3 trial in patients aged 2-14 years, week 4 IGA success was 47.1% with difamilast 1% vs. 18.1% with vehicle (P<0.001). The most common adverse reactions (≥1% and greater than vehicle) was nasopharyngitis. Less common adverse reactions in patients treated with difamilast included application site folliculitis, contact dermatitis, application site rash, and molluscum contagiosum.
Epinephrine nasal spray 2 mg/0.1 mL
Trade Name: Neffy®
Company: ALK-Abello Pharmaceuticals
Approval Dates/Comments: In April 2026, Health Canada approved this alpha- and beta-adrenergic receptor agonist formulation indicated for emergency treatment of type I allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products and other allergens as well as idiopathic or exercise-induced anaphylaxis in adults and children weighing 30 kg or more. This needle-free epinephrine nasal spray has a 30-month shelf life and no special storage requirements. FDA approval was granted in the summer of 2024 – in the US it is also available in a 1 mg dose for children weighing 15-30 kg, but this dose has not been approved in Canada.
