Bimekizumab

FDA approves UCB’s Bimzelx 320 mg single-injection device for moderate-to-severe plaque psoriasis and active psoriatic arthritis, offering a more convenient option. Bimzelx, a selective IL-17A and IL-17F inhibitor, simplifies dosing for maintenance regimens, enhancing patient experience.

FDA approves new 2 mL prefilled syringe and autoinjector of UCB’s bimekizumab-bkzx (Bimzelx), each containing 320 mg, for single-injection every 8 weeks in moderate-to-severe plaque psoriasis patients. This expands administration options and enhances patient convenience.

FDA approves 320 mg pre-filled syringes and autoinjectors of Bimzelx for active psoriatic arthritis with coexisting moderate-to-severe plaque psoriasis, available in the U.S. in Q1 2025.

UCB receives FDA approval for 320 mg single-injection device presentations of Bimzelx (bimekizumab-bkzx), offering convenience and enhanced patient experience for moderate-to-severe plaque psoriasis and active psoriatic arthritis.

UCB announces FDA approval of 2 mL pre-filled syringe and autoinjector, each containing 320 mg of BIMZELX® (bimekizumab-bkzx), offering single-injection options for patients requiring a 320 mg dose. These new presentations aim to enhance convenience and patient experience, with availability in the U.S. expected in Q1 2025.

UCB announces FDA approval of 2 mL pre-filled syringe and autoinjector, each containing 320 mg of BIMZELX® (bimekizumab-bkzx), offering single-injection options for patients requiring a 320 mg dose. This follows the European Commission's approval in August 2024. The new devices will be available in the U.S. in Q1 2025.

FDA approves Bimzelx (bimekizumab-bkzx) for active ankylosing spondylitis (AS), nonradiographic axial spondyloarthritis (nr-axSpA), and psoriatic arthritis. Bimzelx, a dual IL-17A/IL-17F inhibitor, aims to reduce inflammation and improve symptoms. Clinical trials BE MOBILE 1 and 2 showed significant ASAS40 responses, with sustained improvements in inflammation, pain, and quality of life. Common side effects include the common cold, upper respiratory tract infection, and oral candidiasis.

UCB announces BE BOLD, a Phase 3b study comparing BIMZELX® (bimekizumab) with SKYRIZI® (risankizumab) in treating active psoriatic arthritis (PsA), marking the first head-to-head study in PsA evaluating an IL-17A and IL-17F inhibitor versus an IL-23 inhibitor. The primary endpoint is ACR50 at Week 16, aiming to provide meaningful comparison on inflamed joints. Top-line results expected in 2026.

Zelma Chiesa Fuxench and Mona Shahriari discuss psoriasis research gaps in skin of color. Bimzelx approved for non-radiographic axial spondyloarthritis. FDA and EC supported by delgocitinib cream trials. HAE cutaneous signs for early diagnosis. Comorbidities in alopecia areata treatment. Dermatologists offer holistic skin health. PDUFA target action date set for May 2025. Conference highlights and VYNE's positive clinical trial results. Farberg on Geriatrics data. Bunick on zasocitinib's clinical trials. Rinvoq's effectiveness for AD with head and neck involvement. SERENA study's 3-year results. Shahriari on research diversity. Rise in STI diagnoses. HS flare-up reductions. Zasocitinib's AI-driven design. Bimekizumab's PASI100 results. Eyerich on upadacitinib's skin clearance. Lesion count reductions. Burnett on clinical data diversity. Gooderham on EADV 2024 highlights. Mostaghimi on deuruxolitinib for severe AA.

FDA approves Bimzelx (bimekizumab-bkzx) for active psoriatic arthritis, nonradiographic axial spondyloarthritis, and ankylosing spondylitis, targeting IL-17A and IL-17F cytokines, with 160 mg subcutaneous injection every four weeks.