FDA Approves Bimzelx for Additional Uses

On Thursday, Sept. 26, 2024, the U.S. Food and Drug Administration (FDA) approved Bimzelx (bimekizumab-bkzx) for treating adults with various chronic inflammatory conditions. Specifically, Bimzelx is now approved for adults with active psoriatic arthritis (PsA), active nonradiographic axial spondyloarthritis (nr-axSpA) with signs of inflammation, and active ankylosing spondylitis (AS).

Bimzelx functions by selectively inhibiting two critical cytokines that drive inflammatory processes: interleukin 17A (IL-17A) and interleukin 17F (IL-17F). The FDA recommends a dosage of 160 mg administered via subcutaneous injection every four weeks across all three conditions.

The FDA's approval for PsA was backed by two phase 3 clinical trials. In these studies, Bimzelx demonstrated statistically significant improvements at the 16-week mark in both joint and skin symptoms when compared to a placebo. These improvements were observed in both biologic-naive patients and those who had inadequate responses to tumor necrosis factor inhibitors. The positive effects were sustained up to week 52.

For active nr-axSpA and AS, two other phase 3 trials provided the supporting data. These studies also showed statistically significant improvements in signs and symptoms at week 16 compared to a placebo. Similar to the PsA studies, these benefits were sustained through week 52.

Emmanuel Caeymaex, the executive vice president and chief commercial officer at UCB, expressed optimism about the FDA's approval of Bimzelx for the three new indications. "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," Caeymaex stated.

These approvals were granted to UCB, the pharmaceutical company responsible for Bimzelx.