Belgium-based biopharmaceutical company UCB has announced that the US Food and Drug Administration (FDA) has granted approval for Bimzelx (bimekizumab), an interleukin 17A (IL-17A) and IL-17F targeted antibody, in three new indications. The FDA’s approval expands the use of Bimzelx to treat adults with active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS).
This development marks Bimzelx’s approval for four distinct autoimmune conditions in the US market, following its initial approval in October 2023 for the treatment of moderate-to-severe plaque psoriasis. Bimzelx is administered subcutaneously every 4 weeks for psoriatic arthritis and axSpA. UCB highlights that global clinical trials have demonstrated the drug’s IL-17 mechanism, which directly targets the inflammatory processes of these autoimmune diseases, helping patients achieve a rapid and sustained clinical response up to two years.
Bimzelx joins the market as the fourth IL-17 targeted molecule, alongside Novartis’ Cosentyx (secukinumab), Eli Lilly’s Taltz (ixekizumab), and Amgen’s Siliq (brodalumab). UCB secured its first approval for Bimzelx in the Chinese market in July 2024.- Flcube.com
