UCB Seeks Approval of Bimzelx Across Multiple Indications Based on Favorable Trial Data

Bimzelx. Credit: UCB.

UCB has filed supplemental biologics license applications (sBLA) to the FDA for Bimzelx (bimekizumab-bkzx) across three new indications for psoriatic arthritis, non-radiographic axial spondylarthritis, and ankylosing spondylitis, as well as a fourth for hidradenitis suppurativa (HS).¹

Bimzelx, a humanized monoclonal IgG1 antibody, was developed to selectively inhibit two cytokines that affect inflammatory processes—interleukin (IL)-17A and IL-17F. Bimzelx was approved by the FDA in October 2023 for adults with moderate to severe plaque psoriasis who are eligible for systemic therapies or phototherapies. It was the first and only approved psoriasis treatment that selectively inhibits IL-17A and IL17F inhibitor.²

Data presented at the Conference of the European Hidradenitis Suppurativa from the Phase III BE HEARD I (NCT04242446) and BE HEARD II (NCT04242498) trials showed the efficacy and safety of Bimzelx treating adults with moderate to severe HS. The randomized, double-blind, placebo-controlled trials had the primary endpoint of a decrease from baseline in the total abscess and inflammatory nodule count of at least 50% without an increase in abscess or draining tunnel count at week 16 (HiSCR50). The trial’s secondary endpoint was HiSCR of at least 75% (HiSCR75) at week 16.³

The study showed that at week 16, more patients administered Bimzelx achieved an International Hidradenitis Suppurativa Severity Score System of 55 compared with placebo, which was either sustained or increased by week 48. Further, those switched over to Bimzelx from placebo showed comparable responses to patients administered continuous treatment with Bimzelx.³

Between 69.5% and 74.8% of patients achieving HiSCR50 at week 16 reported a quality-of-life rating of “none or mild” at week 16. A greater proportion of patients reported the “none or mild” rating if they achieved HiSCR75 (77.2%-84.3%) or HiSCR90 (80.0%-89.3%) at week 16, with similar findings observed at week 48.

FDA-approval of the drug for moderate-to-severe plaque psoriasis was based on findings from the Phase III, multicenter, randomized, placebo and/or active comparator-controlled BE READY, BE VIVID, and BE SURE trials. These trials showed the efficacy and safety of Bimzelx in 1480 adult patients with moderate-to-severe plaque psoriasis.

Patients administered Bimzelx achieved superior levels of skin clearance at week 16 compared with patients administered ustekinumab and adalimumab, as measured by at least a 90% improvement in the Psoriasis Area & Severity Index (PASI 90) and an Investigator’s Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1), according to UCB. Key secondary endpoints included PASI 75 at week four and PASI 100 at week 16.²

“What we do know from having had Bimzelx launch in over 40 countries and our data, is that we have over 12,000 people living with psoriasis that are leading into the results you see from our Phase III studies,” said Camille Lee, SVP, head of US immunology, UCB, in an interview with PharmExec.

“In those studies, we see that more than 80% of patients that are treated with Bimzelx achieved clear or close to clear skin with more than half achieving complete clearance at week 16. It's critical that a patient starts to feel the benefit as early on as treatment. The other critical point is that we're coming with three year data. Most products that launch usually only have 12 months.”⁴

UCB said that it expects FDA action and potential approvals for the sBLA indications before the end of 2024.

References

1. UCB on Growth Path for a Decade Plus. UCB. News release. February 28, 2024. Accessed February 29, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-on-growth-path-for-a-decade-plus

2. BIMZELX Approved by the U.S. FDA for the Treatment of Adults with Moderate-to-Severe Plaque Psoriasis. UCB. News release. October 18, 2023. Accessed February 29, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/bimzelx-approved-by-the-us-fda-for-the-treatment-of-adults-with-moderate-to-severe-plaque-psoriasis

3. Latest analyses of bimekizumab phase 3 studies in moderate to severe hidradenitis suppurativa to be presented at EHSF 2024. UCB. News release. February 9, 2024. Accessed February 29, 2024. https://www.ucb.com/stories-media/Press-Releases/article/Latest-analyses-of-bimekizumab-phase-3-studies-in-moderate-to-severe-hidradenitis-suppurativa-to-be-presented-at-EHSF-2024

4. Tracy, D. Q&A With UCB's Camille Lee on New Psoriasis Medication Approval. PharmExec. Published December 6, 2023. Accessed February 29, 2024. https://www.pharmexec.com/view/q-a-with-ucb-s-camille-lee-on-new-psoriasis-medication-approval-part-1