FDA approves Bimzelx for three new indications

The U.S. Food and Drug Administration has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS).

Bimzelx selectively inhibits two key cytokines driving inflammatory processes—interleukin 17A (IL-17A) and interleukin 17F (IL-17F). The FDA recommended dosage of Bimzelx across the three indications is 160 mg by subcutaneous injection every four weeks.

The expanded indication for PsA is supported by two phase 3 studies in which Bimzelx (compared with placebo) led to statistically significant improvements at week 16 in both joint and skin symptoms, across biologic-naive and tumor necrosis factor inhibitor-inadequate responder populations, with improvements sustained to week 52. For active nr-axSpA and AS, two phase 3 studies showed statistically significant improvements in signs and symptoms with Bimzelx (compared with placebo), which were also sustained to week 52.

“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, the executive vice president and chief commercial officer at UCB, said in a statement.

These approvals for Bimzelx were granted to UCB.

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