Bimzelx® (bimekizumab-bkzx) from UCB is now under FDA review for a total of four potential new indications. Supplemental biologics license applications (sBLA) were submitted in February for three spondyloarthritides indications: psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS). A fourth sBLA for hidradenitis suppurativa (HS) has also been submitted to FDA.
UCB expects FDA action and potential approvals for all indications before the end of 2024. The company provided updates on the sBLA submissions as part of an update in which management predicted ongoing growth through the next decade.
“In 2024, we will accelerate our investments launching three products around the globe, including a direct to consumer (DTC) campaign in the US for Bimzelx®, previously slated for 2023,” said UCB CFO Sandrine Dufour, in a statement. “We are on our way to deliver growth for a decade plus. Our financial guidance for 2024 foresees a growing top line and an almost stable adjusted EBITDA margin. Our commitment for 2025 for growing the top line to at least € 6 billion and an improved margin stands.”