Less than a year after snagging its first FDA approval in psoriasis, UCB’s blockbuster hopeful Bimzelx has picked up three more indications to add to its growing resume of inflammatory disease treatment.
The FDA cleared 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). The med is the first IL-17A/F inhibitor approved to treat the three indications, UCB noted in a 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,” the company’s chief commercial officer, Emmanual Caeymaex, said in the release.
The three new nods stand to bolster the company’s stated peak sales expectations of at least 4 billion euros ($4.4 billion) for Bimzelx. Even still, there’s more to come for the drug. The FDA accepted UCB’s bid for another use, this time in hidradenitis suppurativa, back in April.
As of July, the therapy has reached more than 35,000 patients globally, CEO Jean-Christophe Tellier commented in the company’s half-year financial report. During the period, Bimzelx picked up 215 million euros ($239 million) in sales, with the bulk coming from Europe. Tellier gave Bimzelx the title of a "best-in-disease" profile with a "tremendous value proposition" in an interview last year.
While the FDA initially delayed an approval in 2021 based on manufacturing issues, regulators in Europe cleared the med in 2022 and have since approved it in all four of its follow-up indications, including in hidradenitis suppurativa.
Despite the hold-up, Bimzelx’s launch in psoriasis has been “the strongest” in the U.S. market against all biologics based on prescriptions, UCB’s head of U.S. immunology Camile Lee said in an interview with Fierce Pharma.
Lee also highlighted the drug’s rapid onset of treatment effect and sustained benefits over two years as demonstrated by 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 added.
The company expects its full-year revenue to come in near 5.7 billion euros ($6.3 billion). Along with Bimzelx, the sales growth should be driven by ongoing global launches of its recently approved generalized myasthenia gravis meds Rystiggo and Zilbrysq, the drugmaker said in an earnings call earlier this year.