New Administration Options Approved for Bimekizumab for Psoriasis, PsA

The FDA has approved new prefilled administrations of UCB’s bimekizumab-bkzx (Bimzelx), a 2 mL prefilled syringe and prefilled autoinjector, each containing 320 mg.¹

“Our goal with these single-injection regimens is to strengthen and expand administration options, increase convenience and enhance the individual patient experience,” Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, Chief Commercial Officer, UCB, said in a statement.¹ “With the new device presentations, people with moderate-to-severe plaque psoriasis who receive a bimekizumab-bkzx maintenance dose of 320 mg will have the option of a single-injection every 8 weeks.”

The newly approved administration options for bimekizumabadd to the currently available 1 mL administration options which contain 160 mg of bimekizumab-bkzx, and will allow patients that require a 320 mg dose of bimekizumab-bkzx to have options for single-injection administration.

The new administrations were approved following studies demonsrtating the bioequivalence of bimekizumab-bkzx 320 mg given as 1 2 mL subcutaneous injection, and bimekizumab-bkzx 320 mg given as 2 1 mL subcutaneous injections, in healthy study participants.

Bimekizumab was approved for adults with moderate-to-severe plaque psoriasis in October 2023 and for adults with active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS) in September 2024.^2,3

"In Phase 3 clinical studies, the clinically meaningful and consistent clinical response in patients who had a previous inadequate response to TNF inhibitors, and in patients who were new to biologics, suggest that bimekizumab-bkzx has the potential to be an important new treatment option in our armamentarium for adults with psoriatic arthritis," trial investigator Joseph F. Merola, MD, MMSc, Chair of Dermatology, and Professor, Dermatology and Rheumatology, UT Southwestern Medical Center, Dallas, said in a statement.² "The approval of bimekizumab-bkzx for the treatment of active psoriatic arthritis provides a new, differentiated treatment option for the rheumatology and dermatology communities."

BIMZELX’s approval for active PsA was supported by data from the phase 3 the BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581) trials, in which BIMZELX met the primary endpoint of American College of Rheumatology 50 (ACR50) response at Week 16 versus placebo, and all ranked secondary endpoints, with consistency across both biologic-naïve and TNF inhibitor‑inadequate responder (TNFi-IR) patients. These responses on ACR50, Psoriasis Area and Severity Index 90 (PASI90), minimal disease activity (MDA), and PASI100, were sustained to week 52.^4,5

REFERENCES

1. UCB receives U.S. FDA approval for 320 mg single-injection device presentations of BIMZELX[®] (bimekizumab-bkzx). News release. October 14, 2024. https://www.ucb.com/stories-media/Press-Releases/article/UCB-receives-US-FDA-approval-for-320-mg-single-injection-device-presentations-of-BIMZELXR-bimekizumab-bkzx

2. UCB Announces U.S. FDA Approvals for BIMZELX® (bimekizumab-bkzx) for the Treatment of Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis, and Ankylosing Spondylitis. News release. UCB. September 23, 2024.

3. UCB. BIMZELX® Approved by the U.S. FDA for the Treatment of Adults with Moderate-to-Severe Plaque Psoriasis. Press release. Published October 18, 2023. 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

4. Ritchlin CT, Coates LC, McInnes IB, et al. Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. Ann Rheum Dis. 2023;82:1404–14.

5. Coates LC, Landewé R, McInnes IB, et al. Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL. RMD Open. 2024;10:e003855.