UCB announced that the U.S. Food and Drug Administration (FDA) has approved BIMZELX (bimekizumab-bkzx) for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.1 BIMZELX is the first and only approved psoriasis treatment designed to selectively inhibit two key cytokines driving inflammatory processes - interleukin 17A (IL-17A) and interleukin 17F (IL-17F). The approval of BIMZELX is supported by data from three Phase 3, multicenter, randomized, placebo and/or active comparator-controlled trials (BE READY, BE VIVID, and BE SURE), which evaluated the efficacy and safety of BIMZELX in 1,480 adults with moderate-to- severe plaque psoriasis. Psoriasis affects more than 7.5 million adults in the U.S. and impacts much more than the skin itself.5 In addition to the recognized skin symptoms such as itching and flaking, psoriasis can place strains on patients and their families, impacting work, relationships and home lives.6,7 A U.S. observational study (n=846) reported that only one in four patients achieved self-assessed complete skin clearance after six months of treatment with biologics highlighting the burden of plaque psoriasis and the need for additional new treatment options.

The FDA recommended dosage of BIMZELX for psoriasis patients is 320 mg (given as two subcutaneous injections of 160 mg each) at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter.1 For patients weighing =120 kg, a dose of 320 mg every 4 weeks after week 16 may be considered. BIMZELX may be administered by a healthcare professional, or a patient may self-inject after proper training. BIMZELX is available as an autoinjector and a pre-filled syringe.

BIMZELX will be available in the U.S. in approximately one month. Key Findings from the Phase 3 Clinical Development Program: The efficacy and safety of BIMZELX were evaluated in three Phase 3 studies, versus placebo and ustekinumab (BE VIVID), versus placebo (BE READY), and versus adalimumab (BE SURE). All studies met their co-primary endpoints and all ranked secondary endpoints; Patients treated with BIMZELX achieved superior levels of skin clearance at week 16, compared to those who received ustekinumab (ranked secondary endpoint, BE VIVID; p<0.0001), placebo (co-primary endpoint, BE READY and BE VIVID; p<0.0001) and adalimumab (co-primary endpoint, BE SURE; p<0.001), as measured by at least a 90 percent improvement in the Psoriasis Area & Severity Index (PASI 90) and an Investigator's Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1).2,3,4 Ranked secondary endpoints included PASI 75 at week 4 and PASI 100 (complete skin clearance) at week 16.

Key findings across all studies include: Clear or Almost Clear Skin: More than eight out of 10 patients receiving BIMZELX (320 mg every four weeks [Q4W]) achieved PASI 90 and IGA 0/1 at week 16. Complete Skin Clearance: Approximately six out of 10 patients receiving BIMZELX (320 mg Q4W) achieved PASI 100 at week 16. Speed of Response: Clinical responses achieved with BIMZELX were rapid, with more than seven out of 10 patients achieving PASI 75 at week 4 following one dose (320 mg).

Maintenance of Response: Clinical responses achieved with BIMZELX at week 16 (PASI 90 and PASI 100) were maintained for up to one year. Long-term data showed that clinical responses were maintained in the vast majority of patients through to three years of BIMZELX treatment.