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UCB’s sBLA for Bimzelx accepted by FDA for HS treatment
UCB has announced that the US Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for Bimzelx (bimekizumab-bkzx), for the treatment ofadultpatientswithmoderate-to-severe hidradenitis suppurativa (HS).
An additional sBLA for bimekizumab-bkzx 2ml device presentations has also been accepted for review.
The drug is an IL-17A and IL-17F inhibitor, and these recent acceptances are only two of five sBLAs accepted by the FDA for this drug in 2024. Previously, the FDA has accepted applications in psoriatic arthritis, non-radiographic axial spondyloarthritis andankylosingspondylitis.Ithasalsobeen approved in the US for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Emmanuel Caeymaex, executive vice president of immunology solutions and head of US at UCB, commented: “We are excited to share the progress on our FDA applications. The most recent sBLA seeks approval for bimekizumab-bkzx in moderate-to-severe hidradenitis suppurativa, and is aligned to our goal of expanding the reach of bimekizumab to more patients living with IL-17 mediated diseases. In addition, the sBLA for the 2ml device presentations aims to offer increased convenience for patients. Today, one dose of bimekizumab in moderate-to-severe plaque psoriasis, is administered as two 1mL injections. Approval of the 2ml device presentations would mean that patients would have an alternative one injection regimen option.”
According to the company’s press release, ‘The sBLA for the additional device presentations seeks approval of bimekizumab-bkzx 2ml safety syringe and 2ml autoinjector with the aim of providing a second option to the currently approved 1mL presentations’.
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