Words by Isabel O’Brien
In good news for the hidradenitis suppurativa (HS) community, UCB has announced that its novel IL-17A and IL-17F inhibitor has been approved by the FDA for the treatment of moderate to severe cases of the disease, which is a chronic and painful skin condition that currently has limited treatment options.
This approval of bimekizumab-bkzx follows the results of two Phase 3 studies, which demonstrated that the inhibitor significantly improved the signs and symptoms of HS compared to placebo.
The lead investigator in the Phase 3 trials, Alexa B. Kimball, Professor of Dermatology, Harvard Medical School, commented on the approval “The approval of [bimekizumab-bkzx] in moderate to severe hidradenitis suppurativa is welcome given the substantial unmet clinical needs and limited number of treatment options available today.”
HS is a condition affecting approximately 1 in 100 people, characterised by painful lumps, abscesses and draining tunnels in the skin, typically in areas like the armpits, groin and buttocks. The condition causes significant pain and impacts quality of life, with limited effective treatments currently available.
Emmanuel Caeymaex, Executive Vice President and Chief Commercial Officer, UCB, called the FDA’s decision a “milestone” for the company in its mission to address unmet needs across a range of IL-17 mediated diseases. He added that it was an “indication of our commitment to delivering innovative treatments and raising the standard of care”.
This approval adds to UCB’s growing success with bimekizumab-bkzx, which was first approved in the US in 2023 for moderate-to-severe plaque psoriasis. Since then, it has been approved for three other immune-mediated diseases, with this win bringing the total number of approved indications in the US to five. With this new approval in the bag, UCB’s inhibitor could even be on track for blockbuster status in the future.
