Approval based on phase 3 trials showing clinical response at 16 weeks, with sustained benefit at 48 weeks
By Lori Solomon HealthDay Reporter
MONDAY, Nov. 25, 2024 (HealthDay News) — The U.S. Food and Drug Administration has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with moderate-to-severe hidradenitis suppurativa.
Bimzelx becomes the first and only approved medicine designed to selectively inhibit interleukin 17F in addition to interleukin 17A and is the fifth indication for Bimzelx in the United States.
The approval is supported by data from two phase 3 studies of adults with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II). Compared with placebo, results showed that a higher proportion of patients treated with Bimzelx achieved ≥50 percent improvement in signs and symptoms of hidradenitis suppurativa at week 16, which was the primary end point as measured by Hidradenitis Suppurativa Clinical Response (HiSCR50). Bimzelx treatment also resulted in clinically meaningful improvements in the secondary end point, HiSCR75 at week 16, compared with placebo. Clinical responses were sustained to week 48, with no new safety signals reported.
“The approval of Bimzelx in moderate-to-severe hidradenitis suppurativa is welcome given the substantial unmet clinical needs and limited number of treatment options available today,” BE HEARD investigator Alexa B. Kimball, M.D., from the Beth Israel Deaconess Medical Center in Boston, said in a statement.
Approval of Bimzelx was granted to UCB.
Copyright © 2024 HealthDay. All rights reserved.
