FDA Greenlights BIMZELX for Chronic Hidradenitis Suppurativa

• BIMZELX is the first therapy approved for hidradenitis suppurativa (HS) that targets both IL-17A and IL-17F
• Clinical trials showed significant symptom improvement sustained over 48 weeks with no new safety signals
• The approval addresses an unmet need in HS and highlights UCB’s commitment to immunological innovation

The Food and Drug Administration (FDA) has approved BIMZELX® (bimekizumab-bkzx) for adults with moderate-to-severe hidradenitis suppurativa (HS), making it the first treatment to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F). 

According to a press release from the manufacturer (UCB), the results from the Phase 3 BE HEARD I and II studies showed more patients receiving BIMZELX achieved at least a 50% improvement in HS symptoms (HiSCR50) at 16 weeks vs. placebo. treatment effects were sustained out to 48 weeks. The treatment also outperformed placebo in achieving HiSCR75 at 16 weeks. No safety signals were observed.

"We are thrilled that with this milestone BIMZELX is now FDA-approved for the treatment of adults with moderate-to-severe hidradenitis suppurativa, a chronic and painful disease affecting approximately one in 100 people," said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact and Chief Commercial Officer, UCB, in a press release. "This is the fifth patient population who may benefit from BIMZELX in the U.S., representing a significant step forward in our mission to alleviate the global burden of immune-mediated inflammatory diseases. This progress underscores our commitment to addressing unmet needs in hidradenitis suppurativa and other immunological conditions, delivering innovative medicines, and raising standards of care."

Source: UCB press release. November 20, 2024