FDA Approves UCB's BIMZELX for Various Inflammatory Conditions

Biopharmaceutical company UCB has secured FDA approval for its medication BIMZELX (bimekizumab-bkzx) for the treatment of three inflammatory conditions in adults. The conditions include active psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) characterized by objective signs of inflammation, and ankylosing spondylitis (AS).

BIMZELX is formulated to specifically target and inhibit interleukin 17A (IL-17A) and interleukin 17F (IL-17F). The FDA recommends a dosage of 160mg bimekizumab, administered through subcutaneous injection every four weeks for adult patients with active PsA, nr-axSpA, and AS. For patients with PsA who also suffer from moderate to severe plaque psoriasis, the dosage remains the same as it does for treating plaque psoriasis alone.

The FDA's approval of BIMZELX for active PsA is based on the results of two Phase III clinical trials, BE OPTIMAL and BE COMPLETE. These studies demonstrated that bimekizumab-bkzx met the primary endpoint of the American College of Rheumatology 50 (ACR50) response at week 16 compared to a placebo, along with all secondary endpoints.

For the nr-axSpA and AS indications, the FDA's decision was supported by data from the Phase III BE MOBILE 1 and BE MOBILE 2 studies. In these trials, bimekizumab-bkzx achieved the primary endpoint of a SpondyloArthritis International Society 40 (ASAS40) response at Week 16, outperforming the placebo, and met all ranked secondary endpoints as well.

UCB's patient impact head, executive vice-president, and chief commercial officer, Emmanuel Caeymaex, commented on the approval, stating that the authorization of BIMZELX for these three new indications underscores the clinical benefits of dual inhibition of IL-17A and IL-17F. This development provides hope for more individuals living with chronic inflammatory diseases to achieve significant health improvements. He highlighted that clinical study results and real-world experiences outside the US have shown that BIMZELX can help patients achieve high levels of clinical response quickly and maintain these results for up to two years.

This FDA approval follows UCB's recent agreement to divest its mature neurology and allergy business in China. The company signed a deal with the CBC Group and Mubadala for $680 million, focusing its efforts on continuing to innovate and bring new treatments to market in other therapeutic areas.