Bimekizumab
- Generic Name
- Bimekizumab
- Brand Names
- Bimzelx
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1418205-77-2
- Unique Ingredient Identifier
- 09495UIM6V
- Background
Bimekizumab is a humanized monoclonal antibody directed towards IL-17, which was approved for use in the EU on August 20, 2021, for the treatment of plaque psoriasis. It is the first IL-17 inhibitor to target both IL-17A and IL-17F. It has demonstrated superior efficacy as compared to another IL-17 inhibitor, secukinumab, as well as ustekinumab (an IL-12/23 inhibitor) and adalimumab (a TNF inhibitor) in the treatment of moderate-to-severe psoriasis, likely owing to its dual inhibition of both IL-17A and IL-17F. Bimekizumab was also granted FDA approval on October 18, 2023.
- Indication
Bimekizumab is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
- Associated Conditions
- Severe Plaque psoriasis, Moderate Plaque psoriasis
- Associated Therapies
- -
UCB announces extended FDA approvals for BIMZELX for Inflammatory Autoimmune Diseases
UCB's BIMZELX (bimekizumab-bkzx) receives FDA approval extension for treating active psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), and ankylosing spondylitis (AS). BIMZELX, a dual IL-17A and IL-17F inhibitor, demonstrated significant symptom improvements in Phase 3 studies, offering new treatment options for chronic inflammatory diseases.
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UCB gets FDA nod for Bimzelx in three new autoimmune indications
UCB's Bimzelx received FDA expanded approval for active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis, becoming the first dual IL-17A and IL-17F inhibitor for four chronic inflammatory diseases in the US.
UCB's BIMZELX gains FDA approval for inflammatory conditions
UCB receives FDA approval for BIMZELX (bimekizumab-bkzx) to treat adults with active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis. The drug selectively inhibits IL-17A and IL-17F, with a recommended dose of 160mg every four weeks. Approval is based on Phase III studies demonstrating significant clinical responses.
UCB gets expanded FDA approval for psoriasis drug Bimzelx
UCB receives FDA approval for Bimzelx to treat active psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis with inflammation signs.
FDA Expands Bimzelx Approval to Three Additional Autoimmune Indications
FDA approves Bimzelx (bimekizumab-bkzx) for psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis, targeting IL-17A and IL-17F cytokines. Initially approved for plaque psoriasis, Bimzelx showed efficacy in phase 3 studies with common side effects including upper respiratory tract infections, oral candidiasis, and headaches. Available at a list price of $7,552.80 per 1 mL, with potential insurance-based discounts.
FDA OKs Bimzelx for psoriatic arthritis, ankylosing spondylitis, non-radiographic axSpA
FDA approves Bimzelx for psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis, based on four phase 3 studies.
Bimekizumab Approved for Psoriatic Arthritis, Ankylosing Spondylitis, AxSpA
The FDA has approved bimekizumab-bkzx (BIMZELX) for treating active psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), and ankylosing spondylitis (AS) in adults. BIMZELX showed consistent clinical response in Phase 3 studies, including in patients previously unresponsive to TNF inhibitors. The recommended dosage is 160 mg every 4 weeks by subcutaneous injection.
FDA Grants Bimekizumab-Bkzx Approval for Treatment of Chronic Immune-Mediated ...
The FDA approved bimekizumab-bkzx (Bimzelx) for psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis, making it the only IL-17A and IL-17F inhibitor in the US for these conditions.
Drug Development Updates
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