Is Bimzelx Approved for Moderate to Severe Psoriasis?
Yes, Bimzelx (bimekizumab-bkzx) is FDA-approved for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The agency granted approval in October 2023 based on Phase 3 trials showing superior skin clearance compared to placebo and other biologics like adalimumab.[1]
How Does Bimzelx Work for Psoriasis?
Bimzelx is a monoclonal antibody that blocks both IL-17A and IL-17F cytokines, which drive inflammation in plaque psoriasis. This dual inhibition sets it apart from drugs targeting only IL-17A, like Cosentyx (secukinumab), potentially leading to faster and deeper responses in moderate to severe cases.[1][2]
What Do Clinical Trial Results Show?
In three pivotal trials (BE VIVID, BE READY, BE SURE), 85-91% of patients on Bimzelx achieved PASI 90 (90% skin clearance) at week 16, versus 58% for Cosentyx and 54% for adalimumab. Nearly half reached complete clearance (PASI 100). Long-term data through week 52 confirmed sustained efficacy.[1][3]
Who Qualifies for Bimzelx Treatment?
It's indicated for adults with moderate to severe plaque psoriasis unresponsive or intolerant to other therapies. Not approved for mild cases or children. Screening for tuberculosis and hepatitis is required before starting.[1]
Common Side Effects and Risks
Upper respiratory infections occur in 15-20% of patients. Other risks include oral candidiasis (7-14%), fungal infections, and rare inflammatory bowel disease flares. It's a pregnancy category unknown; use contraception during treatment.[1][2]
How Does Bimzelx Compare to Other Psoriasis Biologics?
| Drug | Target | PASI 90 at Week 16 | Dosing |
|------|--------|---------------------|--------|
| Bimzelx | IL-17A/F | 85-91% | 320 mg every 4 weeks (then every 8) |
| Cosentyx | IL-17A | 58-70% | 300 mg every 4 weeks |
| Skyrizi | IL-23 | 75-80% | 150 mg every 12 weeks |
| Tremfya | IL-23 | 75-80% | 100 mg every 8 weeks |
Bimzelx shows higher clearance rates but similar infection risks.[3]
Cost and Access Details
List price is about $7,000 per month, though copay cards can reduce it to $0-5 for eligible patients. Covered by most insurance for approved uses.[4]
When Does Bimzelx's Patent Expire?
Core patents on bimekizumab expire in 2033 in the US, with pediatric exclusivity potentially extending to 2034. No biosimilars are approved yet; check DrugPatentWatch.com for litigation updates.[5]
[1]: FDA Label for Bimzelx (bimekizumab-bkzx), October 2023. https://www.accessdata.fda.gov/drugsatfdadocs/label/2023/761185s000lbl.pdf
[2]: European Medicines Agency Summary of Product Characteristics. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-informationen.pdf
[3]: Gordon KB et al., Lancet (2021); BE VIVID/BE READY trials. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01281-7/fulltext
[4]: GoodRx pricing data, 2024. https://www.goodrx.com/bimzelx
[5]: DrugPatentWatch.com, Bimzelx patents. https://www.drugpatentwatch.com/p/tradename/BIMZELX