UCB Boosts Bimzelx with 3 New FDA Approvals

Less than a year after obtaining its initial FDA approval for psoriasis, UCB's Bimzelx has garnered three additional indications, solidifying its role in the treatment of inflammatory diseases. The FDA has approved Bimzelx for use in adults with active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS). This makes Bimzelx the first IL-17A/F inhibitor approved for these three conditions.

Emmanual Caeymaex, UCB’s chief commercial officer, emphasized the drug's effectiveness in the press release: “In psoriatic arthritis and across the spectrum of axSpA, clinical study results and real-world experience outside the U.S. have highlighted that Bimzelx can help patients achieve high thresholds of clinical response that are rapid in onset and sustained up to two years.”

These new approvals are expected to contribute significantly to the company's goal of achieving peak sales of at least 4 billion euros ($4.4 billion) for Bimzelx. Additionally, the FDA accepted UCB’s application for another indication in April, this time for hidradenitis suppurativa.

By July, Bimzelx had been administered to more than 35,000 patients globally, according to UCB’s CEO, Jean-Christophe Tellier. In the first half of the year, the drug generated 215 million euros ($239 million) in sales, primarily from Europe. Tellier has previously described Bimzelx as having a "best-in-disease" profile and providing a "tremendous value proposition."

Despite initial delays due to manufacturing issues, Bimzelx has gained significant traction. The FDA postponed its approval in 2021, but European regulators cleared the drug in 2022 and have since approved it for all four of its follow-up indications, including hidradenitis suppurativa.

Camile Lee, UCB’s head of U.S. immunology, noted that Bimzelx’s launch in the U.S. market has been exceptionally strong against all other biologics based on prescriptions. She highlighted the drug's rapid onset of effect and sustained benefits over two years, as demonstrated in a 2021 study. “What we’re doing with Bimzelx is bringing higher standards of care so that the patients can live life with a disease versus their disease living their life for them,” Lee said.

UCB anticipates its full-year revenue to be around 5.7 billion euros ($6.3 billion). In addition to Bimzelx, this growth is expected to be driven by the ongoing global launches of its recently approved generalized myasthenia gravis medications, Rystiggo and Zilbrysq.