Bimzelx FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 19, 2023.
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
Bimzelx (bimekizumab-bkzx) is a humanized interleukin-17A and interleukin-17F antagonist for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
- Plaque psoriasis is a chronic, immune-mediated, inflammatory disease that is pathogenically driven by pro-inflammatory cytokines.
- Bimzelx works by selectively and directly inhibiting both interleukin-17A (IL-17A) and interleukin-17F (IL-17F), two key cytokines driving the inflammatory process in plaque psoriasis.
- FDA approval of Bimzelx was supported by data from three Phase 3, multicenter, randomized, placebo and/or active comparator-controlled trials (BE READY, BE VIVID, and BE SURE). All studies met their co-primary endpoints and all ranked secondary endpoints. Patients treated with Bimzelx achieved superior levels of skin clearance at week 16, compared to those who received ustekinumab (ranked secondary endpoint, BE VIVID; p<0.0001), placebo (co-primary endpoint, BE READY and BE VIVID; p<0.0001) and adalimumab (co-primary endpoint, BE SURE; p<0.001). Bimzelx was generally well tolerated.
- Bimzelx is administered by subcutaneous injection at weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter.
- 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 include upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Candida infections, and fatigue.
Development timeline for Bimzelx
Further information
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