Belgian biopharmaceutical company UCB has received the US Food and Drug Administration (FDA) expanded approval for Bimzelx (bimekizumab-bkzx) to include three new autoimmune indications.
The expanded indications include active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA) with signs of inflammation, and ankylosing spondylitis (AS).
Bimzelx is designed to selectively inhibit two key cytokines driving inflammatory processes, interleukin 17A (IL-17A) and interleukin 17F (IL-17F).
In October last year, the drug received the first FDA approval for the treatment of moderate-to-severe plaque psoriasis in adults who are eligible for systemic therapy or phototherapy.
With the expanded approval, Bimzelx became the first and only IL-17A and IL-17F inhibitor approved in the US to treat four chronic immune-mediated inflammatory diseases, said the company.
UCB executive vice president patient impact head and chief commercial officer Emmanuel Caeymaex said: “The approval 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.
“In psoriatic arthritis and across the spectrum of axSpA, clinical study results and real-world experience outside the US have highlighted that BIMZELX can help patients achieve high thresholds of clinical response that are rapid in onset and sustained up to two years.”
The US health regulator recommended a Bimzelx dosage of 160mg, administered as a subcutaneous injection every four weeks, for all three indications.
The FDA approval in active PsA is supported by data from two Phase 3 multicentre, randomised, double-blind, placebo-controlled studies, BE OPTIMAL and BE COMPLETE.
In the two Phase 3 studies, Bimzelx met the primary endpoint at Week 16 and all secondary ranked endpoints, compared to placebo.
American College of Rheumatology 50 (ACR50) is the primary endpoint, and Psoriasis Area and Severity Index 90 (PASI90), and minimal disease activity (MDA) are ranked secondary endpoints.
The drug showed consistent results across both biologic-naïve and TNF inhibitor inadequate-responder (TNFi-IR) populations, with clinical responses sustained to Week 52.
BE OPTIMAL and BE COMPLETE investigator Joseph Merola said: “Bimekizumab-bkzx has the potential to be an important new treatment option in our armamentarium for adults with psoriatic arthritis.
“The approval of bimekizumab-bkzx for the treatment of active psoriatic arthritis provides a new, differentiated treatment option for the rheumatology and dermatology communities.”
FDA approved Bimzelx in active nr-axSpA with signs of inflammation and active AS indications, based on data from the Phase 3 BE MOBILE 1 and BE MOBILE 2 studies, respectively.
In both studies, the drug met the primary endpoint at Week 16 and all ranked secondary endpoints compared with placebo.
Assessment of Spondyloarthritis International Society 40 (ASAS40) response is the primary endpoint, which was consistent across TNFi-naïve and TNFi-inadequate responders.
Also, the clinical responses in both nr-axSpA and AS patients were sustained to Week 52 as assessed by ASAS40, ranked secondary and other endpoints.
