Mavorixafor capsules

Trade Name: Xolremdi™
Company: X4 Pharmaceuticals

Approval Dates/Comments: The US FDA approved oral mavorixafor in April 2024 as the first targeted treatment for the rare, inherited immunodeficiency disease WHIM syndrome – characterized by warts, hypogammaglobulinemia, infections and myelokathexis. Mavorixafor is a small-molecule selective CXCR4 receptor antagonist designed to mobilize white blood cells such as neutrophils, lymphocytes and monocytes from the bone marrow into the peripheral blood circulation to improve immune deficiencies. Treatment is approved for patients ≥12 years of age.

Ustekinumab-aekn SC use

Trade Name: Selarsdi™
Company: Alvotech/Teva Pharmaceutials

Approval Dates/Comments: In April 2024, the FDA approved ustekinumab-aekn, a biosimilar to the branded reference product, Stelara® (ustekinumab, Johnson & Johnson). Approved indications include treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients ≥6 years of age. However, Selarsdi™ is not approved for Crohn’s disease and ulcerative colitis. This regulatory decision is based on results of the Phase 3 AVT04-GL-301 study, which demonstrated comparable efficacy and safety in patients with moderate-to-severe chronic plaque-type psoriasis, including equivalent immunogenicity profile to Stelara®.

Spesolimab-sbzo IV/SC use

Trade Name: Spevigo™
Company: Boehringer Ingelheim

Approval Dates/Comments: In March 2024, the FDA expanded the approval of spesolimab to include the treatment of generalized pustular psoriasis (GPP) in adult and pediatric patients ≥12 years of age and weighing ≥40 kg. The original approval was for treatment of GPP flares in adults. Spesolimab is a novel, humanized selective IgG1 antibody that binds to interleukin-36 receptor (IL-36R), a central signaling pathway in the immune system implicated in the pathogenesis of GPP. The basis of this recent regulatory decision was the positive findings from the EFFISAYIL® 2 clinical trial, a 48-week clinical trial demonstrating spesolimab significantly reduced the risk of GPP flares by 84% vs. placebo. In the trial, no flares were observed after week 4 of subcutaneous spesolimab therapy in the high-dose group. Spesolimab treatment was associated with an increased incidence (≥9 cases per 100 patient-years) of injection site reaction, urinary tract infection, arthralgia, and pruritus.

LetibotulinumtoxinA-wlbg IM use

Trade Name: Letybo™
Company: Hugel

Approval Dates/Comments: In February 2024, the FDA approved the injectable neurotoxin letibotulinumtoxinA-wlbg, a 900 kDa botulinum toxin typeA, to temporarily improve the appearance of moderate to severe glabellar lines in adults.

Bimekizumab SC use

Trade Name: Bimzelx®
Company: UCB Canada Inc.

Approval Dates/Comments: Health Canada approved a new indication for bimekizumab in February 2024 to include adults with active psoriatic arthritis (PsA). Bimekizumab is the first and only biologic therapy that directly inhibits both interleukin (IL)-17A and IL-17F to be approved in Canada. This regulatory decision was supported by data from two Phase 3 clinical trials (BE OPTIMAL and BE COMPLETE) demonstrating treatment with bimekizumab resulted in significant improvement across key disease severity indicators in PsA. The original approval was for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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