UCB Receives U.S. FDA Approval for BIMZELX® (bimekizumab …
4 天之前 · About BIMZELX ® (bimekizumab-bkzx) in the U.S. BIMZELX is a humanized IgG1 monoclonal antibody that selectively binds to IL-17A, IL-17F and IL-17AF cytokines, blocking their interaction with the ...
UCB receives U.S. FDA approval for BIMZELX [®] (bimekizumab …
4 天之前 · Approval is supported by data from the two Phase 3 studies, BE HEARD I and BE HEARD II, in which bimekizumab-bkzx improved the signs and symptoms of disease vs. placebo at Week 16, which were sustained to Week 48 Hidradenitis suppurativa is a chronic, painful and potentially debilitating inflammatory skin disease The milestone marks the fifth indication for bimekizumab-bkzx in the U.S ...
FDA Approves Bimekizumab-Bkzx as Treatment for Hidradenitis …
3 天之前 · “The approval of [bimekizumab-bkzx] in moderate-to-severe hidradenitis suppurativa is welcome given the substantial unmet clinical needs and limited number of treatment options available today,” Alexa B. Kimball, MD, MPH, professor of dermatology at Harvard Medical School, said in a news release.
UCB Announces U.S. FDA Approvals for BIMZELX® (bimekizumab …
ATLANTA, Sept. 23, 2024 /PRNewswire/ -- UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved BIMZELX ® (bimekizumab-bkzx) for the...
BIMZELX® Approved by the U.S. FDA for the Treatment of Adults …
2023年10月18日 · BIMZELX ® (bimekizumab-bkzx) is the first and only IL-17A and IL-17F inhibitor approved for the treatment of adults with moderate-to-severe plaque psoriasis
FDA Approves Bimekizumab for Hidradenitis Suppurativa
3 天之前 · “The approval of bimekizumab for moderate-to-severe HS is tremendous news for people living with HS” and the clinicians who care for them, Jennifer L. Hsiao, MD, director of the HS clinic at ...
FDA approves bimekizumab, now Bimzelx, for active AS and nr …
2024年9月30日 · The U.S. Food and Drug Administration (FDA) has approved Bimzelx (bimekizumab-bkzx) for adults with active ankylosing spondylitis (AS), UCB Biopharm, the therapy’s developer, has announced. The dual interleukin-17A (IL-17A)/IL-17F inhibitor’s approval also extends to adults with active nonradiographic axial spondyloarthritis (nr-axSpA) with ...
UCB Receives U.S. FDA Approval for BIMZELX® (bimekizumab …
4 天之前 · UCB U.S. News Nov 20. UCB Receives U.S. FDA Approval for BIMZELX® (bimekizumab-bkzx) as the First IL-17A and IL-17F Inhibitor for Adults with Moderate-to-Severe Hidradenitis Suppurativa ... About BIMZELX ® (bimekizumab-bkzx) in the U.S. BIMZELX is a humanized IgG1 monoclonal antibody that selectively binds to IL-17A, IL-17F and IL-17AF ...
FDA Approves Bimekizumab for Adults with Hidradenitis …
4 天之前 · Bimekizumab-bkzx is the first treatment targeting IL-17A and IL-17F cytokines for moderate-to-severe hidradenitis suppurativa in adults. Phase 3 trials, BE HEARD I and II, showed significant symptom reduction and sustained clinical responses up to 48 weeks.
UCB announces U.S. FDA approvals for BIMZELX[®] (bimekizumab …
2024年9月23日 · The approval of bimekizumab-bkzx for adult patients with active PsA is supported by data from the Phase 3 BE OPTIMAL and BE COMPLETE studies, in which bimekizumab-bkzx met the primary endpoint of American College of Rheumatology 50 (ACR50) response at Week 16 versus placebo, and all ranked secondary endpoints. 2,3 …