Showing 11-20 of 20 results for "".
- UCB's Bimekizumab Performs Well in Hidradenitis Suppurativahttps://practicaldermatology.com/news/ucbs-bimekizumab-performs-well-in-hidradenitis-suppurativa/2461464/UCB’s bimekizumab may be a promising treatment approach in adults with moderate to severe hidradenitis suppurativa, according to topline results from two Phase 3 studies, BE HEARD I and BE HEARD II. The positive results from these two studies will form the basis of global regulatory license applic…
- UCB Releases Positive Top-line Results for Bimekizumab in Second Phase 3 Psoriatic Arthritis Studyhttps://practicaldermatology.com/news/ucb-releases-positive-top-line-results-for-bimekizumab-in-second-phase-3-psoriatic-arthritis-study/2461047/UCB’s bimekizumab performed well in a Phase 3 study of active psoriatic arthritis patients who were inadequate responders or intolerant to anti-tumor necrosis factor-alpha (anti-TNF-α) therapy. Significantly more patients treated with bimekizumab achieved 50 percent or greater improvement in signs…
- European Commission Approves UCB's BIMZELX for Adults with Moderate to Severe Plaque Psoriasishttps://practicaldermatology.com/news/european-commission-approves-ucbs-bimzelx-for-adults-with-moderate-to-severe-plaque-psoriasis/2460895/The European Commission (EC) has granted marketing authorization for UCB's bimekizumab (Bimzelx) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Bimekizumab is the first approved treatment in the European Union (EU) for moderate to severe …
- FDA Approves Label Update for Cimzia Addressing Low Risk of Fetal Exposurehttps://practicaldermatology.com/news/fda-approves-label-update-for-cimzia-addressing-low-risk-of-fetal-exposure/2457828/The FDA has approved a label update that includes pharmacokinetic data showing negligible to low transfer of Cimzia® (certolizumab pegol) through placenta and minimal transfer to breast milk from mother to infant. The label update is relevant, since approximately 17% of patients in the…
- FDA Approves Cimzia for Moderate to Severe Plaque Psoriasishttps://practicaldermatology.com/news/fda-approves-cimzia-for-moderate-to-severe-plaque-psoriasis/2457747/The FDA has approved extending the label for UCB's Cimzia (certolizumab pegol) to include a new indication in adults with moderate to severe plaque psoriasis. Cimzia is indicated for the treatment of adults with moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or ph…
- FDA Approves UCB’s BIMZELX for the Treatment of Adults with Moderate to Severe Plaque Psoriasishttps://practicaldermatology.com/news/fda-approves-ucbs-bimzelx-for-the-treatment-of-adults-with-moderate-to-severe-plaque-psoriasis/2462079/The U.S. Food and Drug Administration (FDA) has approved BIMZELX (bimekizumab-bkzx) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Bimekizumab is the first and only approved psoriasis treatment designed to selectively i…
- Bimekizumab Demonstrated Sustained Clinical Responses to Week 52 in Phase 3 Studies in PsA, Non-Radiographic Axial Spondyloarthritis, and AShttps://practicaldermatology.com/news/bimekizumab-demonstrated-sustained-clinical-responses-to-week-52-in-phase-3-studies-in-psa-non-radiographic-axial-spondyloarthritis-and-as/2461422/Bimekizumab demonstrated sustained clinical responses to Week 52 in Phase 3 studies in psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis.. The findings were presented at the ACR Convergence 2022 in Philadelphia, November 10–14, 2022. In BE OPTIMAL, clinical …
- Bimekizumab Performs Well in Psoriasis with Results Lasting through Two Yearshttps://practicaldermatology.com/news/bimekizumab-performs-well-in-psoriasis-with-results-lasting-through-two-years/2460929/Interim results from the BE BRIGHT open-label extension (OLE) study showed clinical responses observed in bimekizumab-treated psoriasis patients during the first 16 weeks of BE SURE were sustained through to two years of treatment with continuous maintenance dosing, UCB reports. These data, toget…
- New Bimekizumab Phase 3 Data Presented at EADVhttps://practicaldermatology.com/news/new-bimekizumab-phase-3-data-presented-at-eadv/2460594/UCB shared detailed results of the head-to-head Phase 3 BE SURE study, which demonstrated that patients treated with investigational IL-17A and IL-17F inhibitor bimekizumab achieved superior skin clearance, as compared to adalimumab, in adults with moderate to severe plaque psoriasis. These finding…
- Bimekizumab Phase 3 Data Show Superior Skin Clearance in Psoriasis vs. Placebo and Ustekinumabhttps://practicaldermatology.com/news/bimekizumab-phase-3-data-show-superior-skin-clearance-in-moderate-to-severe-psoriasis/2460421/UCB shared first presentations of data from the Phase 3 clinical development program of bimekizumab, its investigational IL-17A and IL-17F inhibitor, as part of a virtual session for the American Academy of Dermatology (AAD) 2020 Annual Meeting. Patients treated with bimekizumab achieved superior s…
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