New Indications Possible for Bimekizumab-bkzx

In February 2024, the U.S. Food & Drug Administration (FDA) accepted for review supplemental biologics license applications (sBLAs) for three new indications of Bimzelx (bimekizumab-bkzx).¹ Bimekizumab-bkzx, a humanized interleukin (IL) 17A and IL-17F antagonist, was previously approved by the FDA (on Oct. 17, 2023) as an injection to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.²

The new indications are for psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS).¹ A fourth sBLA for hidradenitis suppurativa has also been submitted to the FDA.¹

Hidradenitis suppurativa is a chronic inflammatory skin disease that can occur along with psoriasis.^3,4 Hair follicle occlusion may be a primary pathogenic factor. The condition is associated with a chronic cycle of inflammation, healing and scarring. It usually affects intertriginous areas, such as the area under the breasts and the axilla, inguinal, perianal, gluteal and pubic regions. It often occurs in a patient’s 20s or 30s, and leads to significant psychological and emotional burdens. Data pertaining to the prevalence of hidradenitis suppurativa are scarce, but estimates range from 0.3–1.7%.³ Hidradenitis suppurativa can be mistaken for acne. Treatments can include antibiotics, glucocorticoids, hormones, biologics, retinoids, pain management and/or surgery. A dermatologist can assist in making an accurate diagnosis.

Bimekizumab is approved to treat psoriasis in more than 40 countries worldwide. It was approved in Europe to treat patients with active PsA, AS and nr-axSpA in May 2023, and was approved in Japan in December 2023.

Available in a prefilled syringe or autoinjector, bimekizumab is administered as two, 1 mL subcutaneous injections (320 mg total) at weeks 0, 4, 8, 12 and 16, then every eight weeks thereafter. For patients weighing at least 120 kg, an increase in frequency to 320 mg every four weeks after week 16 can be implemented.

An sBLA was also submitted for review of a 2 mL safety syringe and a 2 mL autoinjector of bimekizumab-bkzx, with the objective of improving the patient experience.¹

The manufacturer (UCB) expects FDA action and potential approval for all of these sBLA indications before the end of 2024.⁵

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. FDA accepts supplemental biologics license applications for Bimzelx (bimekizumab-bkzx) for moderate to severe hidradenitis suppurativa and additional 2 mL device presentations [news release]. UCB Inc. 2024 Apr 4.
2. Prescribing information: Bimzelx (bimekizumab-bkzx). UCB Inc. 2023 Oct.
3. Jfri A, Nassim D, O’Brien E, et al. Prevalence of hidradenitis suppurativa—A systematic review and meta-regression analysis. JAMA Dermatol. 2021 Aug;157(8):924–931.
4. Hidradenitis suppurativa. Mayo Clinic. 2023 Jun 6.
5. UCB on growth path for a decade plus [news release]. UCB Inc. 2024 Feb 28.