UCB adds three more FDA approvals to label for potential blockbuster Bimzelx

UCB’s Bimzelx scored three more FDA approvals on Monday, making it the first and only IL-17A and IL-17F inhibitor approved in the US to treat four chronic immune-mediated inflammatory diseases, according to the company. Bimzelx is now approved for adults with psoriatic arthritis, non-radiographic axial spondyloarthritis with objective signs of inflammation (nr-axSpA), and ankylosing spondylitis (AS). The decision follows previous approvals for moderate-to-severe plaque psoriasis late last year and moderate to severe hidradenitis suppurativa. The approvals were based on four Phase 3 studies that showed the drug was superior to placebo in symptoms of the inflammatory diseases. UCB previously projected peak Bimzelx sales of at least €4 billion ($4.23 billion), but TD Cowen analysts have raised that bar, writing in a note that they have “high conviction” in their €6 billion-plus ($6.7 billion) peak sales estimate for the drug, which they said would be driven by a €3 billion-plus ($3.3 billion) opportunity in hidradenitis suppurativa alone. “We expect the PsA/AS launches should nicely contribute to Bimzelx growth,” the analysts wrote. “Similar to our views, UCB expects prescribing for /PsA patients will be initially driven by dermatologists, as some rheumatologists may be more conservative until experience is gained.” Jefferies analysts have also predicted blockbuster status for Bimzelx, writing on Sunday that their €6.2 billion ($6.9 billion) peak sales estimate includes €2.4 billion ($2.7 billion) in psoriasis and €2.1 billion ($2.3 billion) in hidradenitis suppurativa. In UCB’s half-year report in July, the company reported net sales of €215 million ($239 million) for Bimzelx.

UCB adds three more FDA approvals to label for potential blockbuster Bimzelx

Katherine Lewin

News Reporter

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UCB adds three more FDA ap­provals to la­bel for po­ten­tial block­buster Bimzelx

Katherine Lewin

News Reporter

Sign up to read this article for free.

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