Treats moderate to severe plaque psoriasis. BLA 761151, held by Ucb Inc. Bimekizumab-Bkzx.
As of Nov 13, 2026, BLA 761151 (Bimzelx), held by Ucb Inc, was first approved by FDA on Oct 17, 2023, with 5 approved supplements and 1 published complete response letter.
BIMZELX is a humanized interleukin-17A and F antagonist 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 ( nr-axSpA ) with objective signs of inflammation. Adults with active ankylosing spondylitis ( AS ). Adults with moderate to severe hidradenitis suppurativa (HS). 1.1 Plaque Psoriasis BIMZELX is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 19, 2024 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Oct 11, 2024 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Sep 20, 2024 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Sep 20, 2024 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Sep 20, 2024 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Oct 17, 2023 | Original applicationNew molecular entity, new combination · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| May 12, 2022 | UCB4940 (CDP4940)Facility Inspections | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bimzelx160ML · injectable;injection | Bimekizumab-Bkzx | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
