UCB secures three more FDA approvals for Bimzelx

UCB’s Bimzelx has garnered three additional FDA approvals, positioning it as the first and only IL-17A and IL-17F inhibitor available in the United States for the treatment of four chronic immune-mediated inflammatory diseases. Specifically, Bimzelx has now been approved for adults suffering from psoriatic arthritis, non-radiographic axial spondyloarthritis (nr-axSpA) characterized by objective signs of inflammation, and ankylosing spondylitis (AS). These new approvals build upon previous authorizations for treating moderate-to-severe plaque psoriasis, which were granted late last year, and moderate to severe hidradenitis suppurativa.

The recent FDA approvals were based on the positive outcomes from four Phase 3 clinical studies, which demonstrated that Bimzelx was more effective than a placebo in alleviating symptoms of these inflammatory diseases. Initially, UCB had forecasted that peak sales of Bimzelx could reach at least €4 billion ($4.23 billion). However, analysts from TD Cowen have significantly revised this projection upward. They now express strong confidence that the drug’s peak sales could surpass €6 billion ($6.7 billion), driven primarily by a potential €3 billion-plus ($3.3 billion) market opportunity within the hidradenitis suppurativa segment alone.

Analysts predict that the launches of Bimzelx for psoriatic arthritis and ankylosing spondylitis will significantly contribute to the drug’s overall growth trajectory. They anticipate that initial prescriptions for plaque psoriasis and psoriatic arthritis patients will largely come from dermatologists. In contrast, rheumatologists may adopt a more cautious approach initially until they gain more experience with the drug.

Jefferies analysts have also projected a promising future for Bimzelx, forecasting it to achieve blockbuster status. Their estimates suggest peak sales could reach around €6.2 billion ($6.9 billion), with €2.4 billion ($2.7 billion) expected from psoriasis treatments and €2.1 billion ($2.3 billion) from hidradenitis suppurativa.

In its half-year report published in July, UCB disclosed that Bimzelx had already generated net sales of €215 million ($239 million). This financial performance underscores the drug’s growing market presence and its potential to become a major revenue driver for the company.