FDA BLA · BLA761151

BIMZELX

bimekizumab

Sponsor: UCB INC

APPLICATION

BLA761151

TYPE

BLA

ORIGINAL APPROVAL

2023-10-17

LATEST ACTION

2024-11-19

ROUTE

SUBCUTANEOUS, INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription

Products

BIMZELXPrescription

BIMEKIZUMAB-BKZX 160ML · INJECTABLE · INJECTION

2024-11-19Efficacy · Supplement 10 · standard — Label ↗AP

2024-10-11Efficacy · Supplement 9 · standard — Label ↗AP

2024-09-20Efficacy · Supplement 7 · standard — Label ↗AP

2024-09-20Efficacy · Supplement 5 · standard — Label ↗AP

2024-09-20Efficacy · Supplement 6 · standard — Label ↗AP

2023-10-17Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standard — Letter ↗AP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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