HSE - PCRS

Application Details

HSE Application ID

HSE100025

HTA Number

25019

HTA Link

https://www.ncpe.ie/bimekizumab-bimzelx-hta-id-25019/

Drug

bimekizumab

Brand

Bimzelx®

Applicant

UCB Pharma S.A.

Indication Applied For

Non-radiographic axial spondyloarthritis (nr-axSpA):
Bimekizumab is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).

Ankylosing spondylitis (AS, radiographic axial spondyloarthritis): 
Bimekizumab is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.

Application Date

06/03/2025

Marketing Authorisation Date

05/06/2023

Application Status

Proposal from Applicant Under Review

31/07/2025

Awaiting Proposal from Applicant

17/07/2025

Applicant Meeting Held with CPU

17/07/2025

Rapid Review Completed

03/04/2025

Rapid Review Commissioned

06/03/2025

Pricing and Reimbursement Application Complete

06/03/2025

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