FDA OKs Bimzelx for psoriatic arthritis, ankylosing spondylitis, non-radiographic axSpA
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Key takeaways:
- The FDA has approved bimekizumab-bkzx for three new indications — PsA, AS and non-radiographic axial SpA.
- The approvals come in the wake of four phase 3 studies.
The FDA has expanded the indication of Bimzelx to include psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis with objective signs of inflammation, according to a press release.
The approvals apply to adults with active disease. The drug had previously been approved for moderate-to-severe plaque psoriasis in October 2023. According to the release from the manufacturer, Bimzelx (bimekizumab-bkzx, UCB) is now the first and only interleukin -17A and IL-17F inhibitor approved by the FDA to treat four chronic immune-mediated inflammatory diseases.
“The approval of Bimzelx in the United States across three new indications highlights the clinical benefit of dual inhibition of both IL-17A and IL-17F for patients, and provides an opportunity for more people living with chronic inflammatory diseases to achieve meaningful outcomes,” Emmanuel Caeymaex, executive vice president, head of patient impact and chief commercial officer at UCB, said in the release.
“In psoriatic arthritis and across the spectrum of axial SpA, clinical study results and real-world experience outside the United States have highlighted that Bimzelx can help patients achieve high thresholds of clinical response that are rapid in onset and sustained up to two years,” he added.
The recommended dose of bimekizumab for all three new indications is 160 mg every 4 weeks via subcutaneous injection. Patients with PsA and concomitant moderate-to-severe plaque psoriasis should follow the dosage and administration recommendations for the latter indication, according to UCB.
The FDA based its approval of Bimzelx for PsA on data from the phase 3 BE OPTIMAL and BE COMPLETE studies, in which the drug achieved the primary endpoint of ACR50 response at week 16 vs placebo. Bimzelx also met all ranked secondary endpoints.
Additionally, the researchers reported consistent results among patients who were either biologic-naïve or had an inadequate response to TNF inhibitors. Clinical responses achieved by week 16 — including ACR50, Psoriasis Area and Severity Index 90 (PASI90), minimal disease activity and PASI100 — were sustained to week 52.
“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,” Joseph F. Merola, MD, MMSc, chair of dermatology at the University of Texas Southwestern, and an investigator on the BE OPTIMAL and BE COMPLETE trials, said in the release.
“The approval of bimekizumab-bkzx for the treatment of active psoriatic arthritis provides a new, differentiated treatment option for the rheumatology and dermatology communities,” he added.
Meanwhile, the approvals for non-radiographic axial SpA and AS follow another pair of phase 3 studies — BE MOBILE 1 and BE MOBILE 2. Bimzelx met its primary endpoint, Assessment of SpondyloArthritis international Society 40 (ASAS40) response at week 16 vs. placebo, as well as all ranked secondary endpoints, in both trials.
According to UCB, ASAS40 responses were consistent in patients with previous inadequate responses to TNF inhibitors, as well as those who had never received them. Week 16 clinical responses were sustained in both the AS and axial SpA populations to week 52.
“In the phase 3 clinical studies, patients treated with bimekizumab-bkzx saw improvements in signs and symptoms and key measures of disease activity at week 16, which were sustained to 1 year and consistent across patients with non-radiographic axial spondyloarthritis and ankylosing spondylitis,” Atul Deodhar, MD, medical director of rheumatology clinics in the Division of Arthritis & Rheumatic Diseases at Oregon Health & Science University, said in the release.
“The U.S. rheumatology community welcomes the approval of bimekizumab-bkzx for use across the entire spectrum of axial spondyloarthritis, especially given that there are few options approved currently to treat both non-radiographic axial spondyloarthritis and ankylosing spondylitis,” he added.
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