Category: bimekizumab

  • UCB’s FDA setback delays competition in U.S. with blockbuster J&J psoriasis drug

    The FDA cited manufacturing issues in turning down UCB’s application seeking approval for bimekizumab, an antibody drug developed to treat moderate-to-severe plaque psoriasis. Bimekizumab is already approved and available in other markets around world, but the FDA rejection delays UCB’s antibody drug from competing in the U.S. for now.

  • FDA rejects UCB’s psoriasis therapy bimekizumab

    The FDA has delivered a blow to UCB’s late-stage pipeline, after saying it is unable to approve its latecomer IL-17 inhibitor bimekizumab for moderate-to-severe plaque psoriasis. The Belgian biotech said today it had received a complete response letter from the US regulator “cannot approve the application in its current form” because observations in FDA inspections […]

  • IL-17 tailender UCB gets EU OK for bimekizumab in psoriasis

    UCB has been bringing up the rear in the IL-17 inhibitor category with bimekizumab, but now has EU approval for the drug and thinks it can mount a stiff challenge to the leaders, including Novartis’ big-selling Cosentyx. The European Commission has cleared the drug as Bimzelx for the treatment of moderate to severe plaque psoriasis […]

  • UCB’s bimekizumab ‘pre-approved’ using NICE fast-track scheme

    UCB’s bimekizumab hasn’t been approved for marketing in Europe yet, but has already been given the nod for NHS use in England and Wales under a new fast-track scheme introduced by NICE. The IL-17 inhibitor is the first to go through a new process aimed at accelerating appraisals for drugs deemed to be low-risk, which […]

  • UCB’s IL-17 latecomer bimekizumab beats Cosentyx in psoriasis trial

    Belgian biopharma company UCB is bringing up the rear of the IL-17 inhibitor category with its bimekizumab drug, so is celebrating new late-stage data showing superiority to the class leader. The BE RADIANT trial pitted bimekizumab against Novartis’ Cosentyx (secukinumab) in the treatment of adults with moderate-to-severe psoriasis, and according to UCB is the first […]