FDA Accepts Supplemental BLA for Bimzelx in Hidradenitis Suppurativa

The FDA has accepted the supplemental biologics license application (sBLA) for Bimzelx (bimekizumab-bkzx) 1 mL to treat adults with moderate-to-severe hidradenitis suppurativa. The FDA is considering a separate BLA for a 2 mL syringe.

Hidradenitis suppurativa is a condition that causes small, painful lumps to form under the skin. This rare condition affects about 1% of the populations and creates abscesses where the folds of the skin meet. It is a complex inflammatory disease but the exact cause it not well known. Women and Black or biracial people are more than likely to get hidradenitis suppurativa than men or Caucasian people.

FDA-approved treatments for moderate-to-severe hidradenitis suppurativa are biologics, including AbbVie’s Humira (adalimumab) and Novartis’ Cosentyx (secukinumab).

Related: Bimzelx, the Newest Psoriasis Treatment, is Now Available

Developed by UCB, Bimzelx is a humanized IgG1 monoclonal antibody that designed to selectively inhibit two key cytokines that drive inflammation – interleukin 17A (IL-17A) and interleukin 17F (IL-17F). It is already available to treat moderate-to-severe plaque psoriasis. UCB launched Bimzelx in November 2023 for the plaque psoriasis indication as both an autoinjector and a pre-filled syringe. The list price is $7,200 per syringe.

“Today, one dose of Bimzelx in moderate-to-severe plaque psoriasis is administered as two 1 mL injections. Approval of the 2mL device presentations would mean that patients would have an alternative one-injection regimen option,” Emmanuel Caeymaex, executive vice president, Immunology Solutions, and head of U.S., UCB, said in a news release.

Bimzelx is available through more than 20 specialty pharmacies, including CVS Specialty Pharmacy and Optum Specialty Pharmacy. A full list of the participating pharmacies can be found here.

The sBLA for the hidradenitis suppurativa indication is supported by data from the phase 3 BE HEARD I and BE HEARD II studies where Bimzelx demonstrated clinically meaningful improvements at week 16. The studies used the Hidradenitis Suppurativa Clinical Response (HiSCR) scale, which is a clinical endpoint to evaluate therapeutic outcomes in patients with hidradenitis suppurative.

The primary endpoint was HiSCR50 at week 16; a secondary endpoint was HiSCR75. HiSCR50 and HiSCR75 are defined as at least either a 50% or 75% reduction from baseline in the total abscess and inflammatory nodule count. These data were presented at 2023 European Academy of Dermatology and Venereology (EADV) Congress in Berlin in October 2023.

Additionally, UCB presented 48-week data from the BE HEARD I and BE HEARD II studies at 2024 at the American Academy of Dermatology in March 2024. Patients with hidradenitis suppurativa who were treated with Bimzelx demonstrated clinically meaningful improvements in pain and greater draining tunnel reductions compared with those treated with placebo.