FDA approval for Bimzelx for hidradenitis suppurativa

The Food and Drug Administration (FDA) has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS), Belgium’s largest drugmaker UCB (Euronext: UCB) announced today.

Bimekizumab-bkzx is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A), according to UCB, whose shares gained 2.1% to 167.80 euros on the news.

“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,” said investigator and lead author of the studies, Dr Alexa Kimball, Beth Israel Deaconess Medical Center and Professor of Dermatology, Harvard Medical School, Boston, USA, noting that, “in the Phase III clinical studies, patients treated with bimekizumab-bkzx achieved deep and sustained clinical responses up to 48 weeks.”