Update on Drugs & Devices: September-October 2025

Trade Name: Anzupgo^®
Company: Leo Pharma

Approval Dates/Comments: The US FDA and Health Canada approved this steroid-free, pan-Janus kinase (JAK) inhibitor treatment in July 2025 and August 2025, respectively, for treating moderate-to-severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Delgocitinib inhibits activation of the signal transducer and activator of transcription (JAK-STAT) pathway, specifically blocking the activity of JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2), and suppressing multiple inflammatory responses that are implicated in the onset and flares of CHE. Regulatory approval was based on two phase 3 trials, DELTA 1 (NCT04871711) and DELTA 2 (NCT04872101), that evaluated the safety and efficacy of delgocitinib in 960 patients, aged ≥18 years, with moderate-to- severe CHE. In both trials, patients were randomized to apply delgocitinib 20 mg/g or vehicle cream twice daily to affected areas on the hands and wrists for 16 weeks. The primary endpoint was the proportion of patients who achieved Investigator’s Global Assessment for CHE (IGA-CHE) treatment success at week 16, defined as a score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline. Findings showed 20% (64/325) of patients treated with delgocitinib achieved IGA-CHE treatment success vs. 10% (16/162) of those receiving vehicle in DELTA 1 (difference, 10% [95% CI, 4-16]; P =.006). Comparably in DELTA 2, 29% (91/313) vs. 7% (11/159) of patients achieved IGA-CHE treatment success in the delgocitinib and vehicle arms, respectively (difference, 22% [95% CI, 16-29]; P <.0001).

Trade Name: Shingrix^®
Company: GSK

Approval Dates/Comments: In July 2025, the FDA approved a prefilled syringe version of this recombinant zoster vaccine (RZV) for the prevention of shingles (herpes zoster). The new prefilled syringe eliminates the need to reconstitute separate vials prior to administration, resulting in simplified vaccine administration for healthcare professionals.

Trade Name: Ekterly^®
Company: KalVista Pharmaceuticals

Approval Dates/Comments: The FDA approval the first and only oral on-demand treatment in July 2025 for acute attacks of hereditary angioedema (HAE) in patients aged ≥12 years. Sebetralstat, a novel plasma kallikrein inhibitor, offers a convenient oral option for patients who previously were limited to receiving either intravenous or subcutaneous treatment. The efficacy and safety of sebetralstat was shown in the phase 3 KONFIDENT clinical trial, which demonstrated sebetralstat achieved significantly faster symptom relief, reduction in attack severity and attack resolution vs. placebo. Additionally, the more real-world KONFIDENT-S open-label extension trial showed that patients were able to treat attacks in a median of 10 minutes following onset.

Trade Name: Amtagvi^®
Company: Iovance Biotherapeutics

Approval Dates/Comments: In August 2025, Health Canada granted conditional approval to this tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma that has progressed on or after at least one prior systemic therapy including a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor, and who have no satisfactory alternative treatment options. This marks the first T cell therapy approved for solid tumor cancer in Canada.