FDA Approves Bimzelx for Inflammatory Skin Disease

hidradenitis suppurativa © Lea - stock.adobe.com

UCB announced today that the FDA has approved Bimzelx (bimekizumab-bkzx) for the treatment of moderate-to-severe hidradenitis suppurativa (HS), a chronic and painful inflammatory skin disease, according to a news release. Bimzelx is also FDA approved to treat adults with moderate-to-severe plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis.

Hidradenitis suppurativa is an autoimmune condition that attacks hair follicles, although experts are unsure why. It is characterized by painful nodules, abscesses and pus-filled channels typically found in the armpits, groin and buttocks. Severe flareups often leave scars. It currently affects about 1% of the United States population and is more common in women, with an onset around puberty, according the HS Foundation.

Bimzelx is a humanized IgG1 monoclonal antibody that selectively binds to three different inflammatory cytokines associated with HS, therefore reducing inflammation.

The approval for the hidradenitis suppurativa indication was the result data from two phase 3 studies, BE HEARD I and BE HEARD II, which had a combined enrollment of 1,014. Bimzelx improved HS symptoms by at least 50% within 16 weeks when compared with placebo. Results were sustained until week 48. Success was measured using HiSCR50, which states that there must be at least a 50% to 75% reduction in abscess and nodule numbers.

“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,” Alexa B. Kimball, M.D., M.P.H., from Beth Israel Deaconess Medical Center, a professor of Dermatology at Harvard Medical School and lead author of the studies, said in the news release.

Patients are to administer a 320 mg subcutaneous injection every two weeks until week 16, starting at week zero. A week 16, injection frequency changes to every eight weeks, and if the patient is over 265 lbs., every four weeks.

Safety was assessed in two placebo-controlled trials which included 839 subjects, 670 of whom were treated with Bimzelx. The most common adverse reactions were upper respiratory tract infections (15%), oral candidiasis (9%) and headache (3%).

The list price is $7,552.80 per 1 mL auto injector or syringe. Pricing depends on insurance coverage and some patients with commercial insurance may pay as little as $5 per dose. The drugmaker UCB will provide Bimzelx for $15 a dose for two years if insurance coverage is delayed or denied.