Biopharmaceutical company UCB has received US Food and Drug Administration (FDA) approval for BIMZELX (bimekizumab-bkzx) to treat adults with three inflammatory conditions.
The product is indicated to treat active psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) with objective inflammation signs, and ankylosing spondylitis (AS).
BIMZELX is designed to selectively hinder both interleukin 17A (IL-17A) and interleukin 17F (IL-17F).
The FDA recommends a dose of 160mg bimekizumab administered via subcutaneous injection every four weeks for adult patients with active PsA, nr-axSpA and AS.
In PsA patients with concurrent moderate to severe plaque psoriasis, the dosage remains consistent with the administration for plaque psoriasis alone.
For the active PsA indication of BIMZELX, the FDA based its approval on the Phase III BE OPTIMAL and BE COMPLETE studies.
Bimekizumab-bkzx met the primary endpoint of the American College of Rheumatology 50 (ACR50) response at week 16 versus placebo, as well as all secondary endpoints.
The FDA's approval for nr-axSpA and AS indications is backed by data from the Phase III BE MOBILE 1 and BE MOBILE 2 studies.
Bimekizumab-bkzx achieved the primary endpoint of SpondyloArthritis International Society 40 (ASAS40) response at Week 16 compared to placebo, as well as all ranked secondary endpoints.
UCB patient impact head, executive vice-president and chief commercial officer Emmanuel Caeymaex stated: “The approval of BIMZELX in the US across three new indications – active psoriatic arthritis, active non-radiographic axSpA with objective signs of inflammation, and active ankylosing spondylitis – 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 latest development comes after the company signed a divestment agreement in China to sell its mature neurology and allergy business to the CBC Group and Mubadala for $680m.
