Bimzelx FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 2, 2024.
FDA Approved: Yes (First approved October 17, 2023)
Brand name: Bimzelx
Generic name: bimekizumab-bkzx
Dosage form: Injection
Company: UCB, Inc.
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis, Ankylosing Spondylitis, Hidradenitis Suppurativa
Bimzelx (bimekizumab-bkzx) is a humanized interleukin-17A and interleukin-17F antagonist for the treatment of plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis, and hidradenitis suppurativa.
- Bimzelx is indicated for the treatment of:
- moderate to severe plaque psoriasis (PSO) in adults who are candidates for systemic therapy or phototherapy.
- adults with active psoriatic arthritis (PsA).
- adults with active non-radiographic axial spondyloarthritis (nraxSpA) with objective signs of inflammation.
- adults with active ankylosing spondylitis (AS).
- adults with moderate to severe hidradenitis suppurativa (HS). - Bimzelx works by selectively and directly inhibiting interleukin-17A (IL-17A) and interleukin-17F (IL-17F), which are two key cytokines that drive the inflammatory process.
- Bimzelx is administered by subcutaneous injection.
- Warnings and precautions associated with Bimzelx include suicidal ideation and behavior, increased risk of infections, liver biochemical abnormalities, and inflammatory bowel disease. Bimzelx should be avoided in patients with active tuberculosis infection. It is recommended that all age-appropriate vaccinations are completed before starting Bimzelx. Live vaccines should be avoided in patients receiving Bimzelx.
- Common adverse reactions:
- in psoriasis and hidradenitis suppurativa patients include upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes simplex infections, acne, folliculitis, other candida infections, and fatigue.
- in psoriatic arthritis patients include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infection.
- in non-radiographic axial spondyloarthritis patients include upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsilitis, transaminase increase, and urinary tract infection.
- in ankylosing spondylitis patients include upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash and vulvovaginal mycotic infection.
Development timeline for Bimzelx
Further information
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