Overview
Bimekizumab is a humanized monoclonal antibody directed towards IL-17, which was approved for use in the EU on August 20, 2021, for the treatment of plaque psoriasis. It is the first IL-17 inhibitor to target both IL-17A and IL-17F. It has demonstrated superior efficacy as compared to another IL-17 inhibitor, secukinumab, as well as ustekinumab (an IL-12/23 inhibitor) and adalimumab (a TNF inhibitor) in the treatment of moderate-to-severe psoriasis, likely owing to its dual inhibition of both IL-17A and IL-17F. Bimekizumab was also granted FDA approval on October 18, 2023.
Indication
Bimekizumab is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Associated Conditions
- Severe Plaque psoriasis
- Moderate Plaque psoriasis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/10 | Phase 3 | Recruiting | |||
2025/03/21 | Phase 1 | Recruiting | |||
2025/01/22 | N/A | Recruiting | |||
2024/12/19 | Phase 2 | Recruiting | |||
2024/10/31 | Phase 3 | Recruiting | |||
2024/10/02 | Phase 3 | Recruiting | |||
2024/08/15 | Phase III and phase IV (Integrated) | Recruiting | |||
2024/05/22 | Phase 3 | Recruiting | |||
2024/03/28 | Phase 4 | Recruiting | |||
2023/08/25 | Phase 3 | Completed |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/20/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| BIMZELX SOLUTION FOR INJECTION IN PRE-FILLED PEN 160MG/ML | N/A | N/A | N/A | 2/19/2025 | |
| BIMZELX SOLUTION FOR INJECTION IN PRE-FILLED PEN 160MG/ML | N/A | N/A | N/A | 2/19/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| BIMZELX bimekizumab 160 mg/1 mL solution for injection auto-injector | 353268 | Medicine | A | 3/24/2022 | |
| BIMZELX bimekizumab 320 mg/2 mL solution for injection auto-injector | 443490 | Medicine | A | 4/8/2025 | |
| BIMZELX bimekizumab 160 mg/1 mL solution for injection safety syringe | 353269 | Medicine | A | 3/24/2022 | |
| BIMZELX bimekizumab 320 mg/2 mL solution for injection safety syringe | 443491 | Medicine | A | 4/8/2025 |
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