Nemolizumab-ilto SC injection
Trade Name: Nemluvio®
Company: Galderma
Approval Dates/Comments: The US FDA approved nemolizumab, a first-in-class interleukin-31 (IL-31) blocker, in August 2024 for the treatment of adults with prurigo nodularis. This humanized monoclonal antibody specifically targets the IL-31 receptor, a key cytokine that drives inflammation. Regulatory approval
was based on positive results from Phase 3 OLYMPIA clinical trials, in which nemolizumab demonstrated significant and clinically meaningful reductions in itch and skin nodules at Week 16, with rapid improvements in itch observed as early as Week 4. It is currently under FDA review for treating atopic dermatitis.
Denileukin diftitox-cxdl IV use
Trade Name: Lymphir™
Company: Citius Pharmaceuticals
Approval Dates/Comments: In August 2024, the FDA approved this reformulated immunotherapy for the treatment of adult patients with relapsed or refractory Stage 1-3 cutaneous T-cell lymphoma who have undergone at least one prior systemic therapy.
Deuruxolitinib phosphate tablets
Trade Name: Leqselvi™
Company: Sun Pharmaceutical
Approval Dates/Comments: In July 2024, the FDA approved oral deuruxolitinib for the treatment of adults with severe alopecia areata. Deuruxolitinib is a selective inhibitor of Janus kinases JAK1 and JAK2, administered at 8 mg twice daily. Regulatory approval was based on positive results from two Phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2. Patients began with a baseline average of 13% scalp hair coverage; at 24 weeks with deuruxolitinib treatment, >30% of patients exhibited 80% hair coverage, and up to 25% demonstrated ≥90% scalp hair coverage.
Roflumilast cream
Trade Name: Zoryve™
Company: Arcutis Biotherapeutics
Approval Dates/Comments: In July 2024, the FDA approved the label expansion for topical roflumilast to include treatment of mild-to-moderate atopic dermatitis in patients ≥6 years of age.
Ustekinumab-ttwe SC/IV injection
Trade Name: Pyzchiva®
Company: Samsung Bioepis (commercialized by Sandoz in the US)
Approval Dates/Comments: The FDA approved ustekinumab-ttwe in June 2024 as an anti-IL-12/IL-23 biosimilar to ustekinumab (Stelara®, Johnson & Johnson) for the same indications as the reference drug, including patients aged ≥6 years with moderate-tosevere plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis in patients ≥6 years of age.
Sofpironium gel, 12.45%
Trade Name: Sofdra™
Company: Botanix Pharmaceuticals
Approval Dates/Comments: The FDA approved sofpironium topical gel 12.45% in June 2024 for the treatment of primary axillary hyperhidrosis in adults and children ≥9 years of age. Sofpironium bromide is a structural analogue of the anticholinergic agent glycopyrrolate, which selectively binds to M3 muscarinic acetylcholine receptors in sweat glands, resulting in decreased sweat production.
Ustekinumab biosimilar
Trade Name: Steqeyma® SC/IV injection
Company: Celltrion Inc.
Approval Dates/Comments: In July 2024, Health Canada approved Stegeyma®, a biosimilar to the reference product Stelara® (Johnson & Johnson), for multiple immune-mediated diseases, including the treatment of adults with moderate-to-severe plaque psoriasis and adults with active psoriatic arthritis.
Lebrikizumab SC injection
Trade Name: Ebglyss™
Company: Eli Lilly Canada
Approval Dates/Comments: In June 2024, Health Canada authorized lebrikizumab, a targeted IL-13 inhibitor, for the treatment of moderate-to severe atopic dermatitis in adults and adolescents ≥12 years of age with a body weight of at least 40 kg, whose disease is not adequately controlled with topical prescription therapies or when those therapies are inadvisable.
