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UCB Adds Hidradenitis Suppurativa as Fifth Indication for Bimzelx

The U.S. FDA has approved UCB SA's Bimzelx (bimekizumab-bkzx) for treating adults with moderate to severe hidradenitis suppurativa, a chronic condition causing painful lumps under the skin, marking its fifth indication.

The U.S. FDA has expanded the label for UCB SA’s Bimzelx (bimekizumab-bkzx) to include hidradenitis suppurativa (HS), a chronic skin disease characterized by painful, boil-like lumps under the skin. This approval marks the fifth indication for Bimzelx, which is a humanized IL-17A and IL-17F antagonist. The drug is now cleared for use in adults suffering from moderate to severe HS, offering a new treatment option for those affected by this challenging condition.
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FDA Approves Bimzelx (bimekizumab-bkzx) for Moderate-to-Severe Hidradenitis Suppurativa

The FDA has approved Bimzelx (bimekizumab-bkzx) for treating moderate-to-severe hidradenitis suppurativa (HS) in adults, offering a new treatment option.
Bimzelx is the first treatment of its kind, selectively inhibiting both IL-17A and IL-17F, providing a novel approach to managing this inflammatory skin condition.

FDA Approves Bimzelx for Moderate-to-Severe Hidradenitis Suppurativa

The FDA has approved Bimzelx (bimekizumab-bkzx) for treating moderate-to-severe hidradenitis suppurativa (HS) in adults, marking a new option for this chronic inflammatory skin disease.
Bimzelx, a humanized IgG1 monoclonal antibody, selectively binds to inflammatory cytokines associated with HS, reducing inflammation and improving symptoms.

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FDA Approves UCB's Bimzelx for Moderate-to-Severe Hidradenitis Suppurativa

The FDA has approved UCB's Bimzelx (bimekizumab-bkzx) for treating moderate-to-severe hidradenitis suppurativa (HS) in adults, offering a new therapeutic option.
Bimzelx is the first approved medicine that selectively inhibits both interleukin 17F (IL-17F) and interleukin 17A (IL-17A), targeting key cytokines in HS.

FDA Approves Bimzelx (bimekizumab-bkzx) for Moderate-to-Severe Hidradenitis Suppurativa

The FDA has approved Bimzelx (bimekizumab-bkzx) for treating moderate-to-severe hidradenitis suppurativa (HS) in adults, marking its fifth indication in the U.S.
The approval was based on data from two Phase 3 trials, BE HEARD I and BE HEARD II, which demonstrated the efficacy and safety of Bimzelx in HS patients.

FDA Approves Bimekizumab (Bimzelx) for Moderate to Severe Hidradenitis Suppurativa

The FDA has approved bimekizumab-bkzx (Bimzelx) for treating moderate to severe hidradenitis suppurativa (HS) in adults, marking a new therapeutic option.
Bimekizumab is the first approved therapy for HS that selectively inhibits both interleukin (IL)-17A and IL-17F, key cytokines in HS inflammation.

FDA Approves UCB's Bimzelx for Moderate-to-Severe Hidradenitis Suppurativa

The FDA has approved UCB’s Bimzelx (bimekizumab-bkzx) for treating moderate-to-severe hidradenitis suppurativa (HS) in adults who have active disease.
Approval was based on positive results from the BE HEARD I and BE HEARD II studies, where Bimzelx demonstrated significant improvement in HS signs and symptoms.

Bimzelx Approved by FDA as First IL-17A and IL-17F Inhibitor for Hidradenitis Suppurativa

The FDA has approved Bimzelx (bimekizumab-bkzx) for treating moderate-to-severe hidradenitis suppurativa in adults, marking its fifth approved indication in the U.S.
Bimzelx is the first and only approved medicine that selectively inhibits both interleukin 17F (IL-17F) and interleukin 17A (IL-17A) for this condition.

Bimekizumab Approved by FDA for Moderate to Severe Hidradenitis Suppurativa

The FDA has approved bimekizumab-bkzx (Bimzelx) for treating moderate to severe hidradenitis suppurativa (HS) in adults.
Bimekizumab is the first approved treatment that selectively inhibits both interleukin 17A (IL-17A) and interleukin 17F (IL-17F).

FDA Approves UCB's Bimzelx (bimekizumab-bkzx) for Hidradenitis Suppurativa

The FDA has approved Bimzelx (bimekizumab-bkzx) as the first IL-17A and IL-17F inhibitor for adults with moderate to severe hidradenitis suppurativa (HS).
Approval was based on Phase 3 trials (BE HEARD I and BE HEARD II) demonstrating significant improvement in HS signs and symptoms at Week 16 and sustained responses at Week 48.

Reference News

[1]
UCB chalks hidradenitis suppurativa as fifth indication for Bimzelx
bioworld.com · Jan 7, 2025

The U.S. FDA approved UCB SA’s Bimzelx for treating hidradenitis suppurativa, a chronic condition causing painful skin l...

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