Bimekizumab-bkzx for SC injection

Trade Name: Bimzelx®
Company: UCB

Approval Dates/Comments: The US FDA approved bimekizumab in October 2023 for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. This novel, humanized immunoglobulin G1 monoclonal antibody works by selectively inhibiting both interleukin (IL)-17A and IL-17F, which are key cytokines implicated in the pathogenesis of chronic immune-mediated disorders. Regulatory approval was based on data from three Phase 3, multicenter, randomized, placebo and/or active comparator-controlled trials (BE READY, BE VIVID, and BE SURE), which assessed the efficacy and safety of bimekizumab in 1480 adults with moderate-to-severe plaque psoriasis. Findings from the three trials reported the 320 mg dose of bimekizumab administered every 4 weeks was associated with ≥80% of treated patients achieving clear or almost clear skin according to the Psoriasis Area Severity Index scores of ≥90% (PASI 90), and Investigators Global Assessment (IGA) scores of 0 or 1, by week 16. About 60% of bimekizumabtreated patients from the Phase 3 studies achieved PASI 100 by week 16. A rapid response was observed, with >70% of treated patients achieving PASI 75 at week 4 after a single dose of bimekizumab, and long-term data demonstrating a maintained clinical response in a vast majority of patients through 3 years of treatment. The most common adverse events associated with bimekizumab (≥1%) were upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other Candida infections, and fatigue.


Clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide 3.1%fixed-dose topical gel

Trade Name: Cabtreo™
Company: Bausch Health

Approval Dates/Comments: In October 2023, the FDA approved this novel, fixed-dose triple-combination (clindamycin phosphate, adapalene and benzoyl peroxide) topical gel indicated for the treatment of acne vulgaris in patients ≥12 years of age. This first and only three-ingredient acne product offers three mechanisms of action by combining antibiotic, retinoid and antibacterial agents for synergistic therapeutic effects.


Roflumilast cream 0.3%

Trade Name: Zoryve®
Company: Arcutis Biotherapeutics

Approval Dates/Comments: In October 2023, the FDA approved an expanded indication for roflumilast cream 0.3% to topically treat children aged 6 to 11 years with plaque psoriasis, including in intertriginous areas. This decision was based on data from the 4-week Maximal Usage Systemic Exposure (MUSE) study, where safety, efficacy, and pharmacokinetic data showed general consistency with data from the pivotal Phase 3 trials DERMIS-1 (NCT04211363) and DERMIS-2 (NCT04211389) in adults.


Nivolumab for IV use

Trade Name: Opdivo®
Company: Bristol Myers Squibb

Approval Dates/Comments: The FDA expanded the approved indications of this programmed death-1 (PD-1) immune checkpoint inhibitor in October 2023 to include adjuvant treatment of patients aged ≥12 years with completely resected stage IIB or IIC melanoma. Nivolumab is the only PD-1 inhibitor indicated for both this patient population and for stage III and stage IV completely resected melanoma.


Secukinumab for IV use

Trade Name: Cosentyx®
Company: Novartis

Approval Dates/Comments: In October 2023, the FDA approved an intravenous (IV) formulation of secukinumab for treating adults with psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. Previously, secukinumab was only authorized as a subcutaneous treatment.

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