Is Bimzelx Approved for Plaque Psoriasis?
Yes, the FDA approved Bimzelx (bimekizumab-bkzx) for adults with moderate-to-severe plaque psoriasis in October 2023. Eli Lilly manufactures it as the first IL-17A and IL-17F inhibitor for this indication, allowing treatment with or without systemic therapies or phototherapy.[1]
How Does Bimzelx Work for Psoriasis?
Bimzelx blocks both IL-17A and IL-17F cytokines, which drive inflammation in plaque psoriasis. Phase 3 trials (BE VIVID, BE READY, BE SURE) showed 85-91% of patients achieving PASI 90 (90% skin clearance) at week 16, compared to 57% on ustekinumab and 7% on placebo.[2]
When Did Bimzelx Get Approved and What's the Dosing?
Approval came October 18, 2023, following EU approval in 2021. Dosing starts at 320 mg (two 160 mg injections) every 4 weeks for 16 weeks, then every 8 weeks. It's subcutaneous and self-administrable.[1]
Who Makes Bimzelx and Is It Under Patent?
Eli Lilly holds exclusive rights. Patents listed on DrugPatentWatch.com extend protection through at least 2037, with challenges possible but none resolved yet.[3] No generics or biosimilars are approved.
How Does Bimzelx Compare to Other Psoriasis Drugs?
| Drug | Target | PASI 90 at Week 16 | Approval Year |
|------|--------|---------------------|---------------|
| Bimzelx | IL-17A/F | 85-91% | 2023 |
| Cosentyx (secukinumab) | IL-17A | 70-80% | 2015 |
| Taltz (ixekizumab) | IL-17A | 70-80% | 2016 |
| Skyrizi (risankizumab) | IL-23 | 75-85% | 2019 |
Bimzelx showed superior skin clearance over Cosentyx and Skyrizi head-to-head, but lacks direct data vs. all competitors.[2]
What Are Common Side Effects and Warnings?
Upper respiratory infections (14-19%), oral candidiasis (7-13%), and herpes infections occur most. Warnings include hypersensitivity, infections, IBD exacerbation, and malignancy risk. Avoid live vaccines.[1]
Is Bimzelx Approved for Other Conditions?
Yes, also for active psoriatic arthritis (2024) and axial spondyloarthritis (2024). Not yet for hidradenitis suppurativa in the US, though approved in Europe.[1]
Cost and Access for Patients
List price is about $6,000-$7,000 per month before insurance. Patient assistance programs from Lilly cover copays up to $16,000/year for eligible patients.[4]
Sources
[1]: FDA Bimzelx Label
[2]: NEJM BE VIVID Trial
[3]: DrugPatentWatch Bimzelx Patents
[4]: Lilly Bimzelx Savings Card