FDA Approves Bimzelx (bimekizumab-bkzx) for Moderate-to-Severe Plaque Psoriasis
Key Insights
The FDA has approved Bimzelx (bimekizumab-bkzx) as the first IL-17A and IL-17F (search) inhibitor for treating moderate-to-severe plaque psoriasis (search) in adults.
Clinical trials demonstrated that Bimzelx provided rapid, complete, and lasting skin clearance for up to one year, with a generally well-tolerated safety profile.
UCB (search) anticipates global peak sales for Bimzelx to reach at least €4 billion, marking a significant advancement in psoriasis treatment.
The U.S. Food and Drug Administration (FDA) has approved Bimzelx (bimekizumab-bkzx) for the treatment of moderate-to-severe plaque psoriasis (search) in adult patients who are candidates for systemic therapy or phototherapy. Developed by UCB (search), Bimzelx is the first and only approved treatment designed to selectively inhibit interleukin 17A (search) (IL-17A) and interleukin 17F (search) (IL-17F (search)), two key cytokines driving inflammatory processes in psoriasis. The approval marks a significant advancement in the treatment of plaque psoriasis, offering a novel mechanism of action to achieve superior levels of skin clearance.
Clinical Trial Efficacy
The approval of Bimzelx is based on data from three Phase 3, multicenter, randomized, placebo and/or active comparator-controlled trials: BE READY, BE VIVID, and BE SURE. These trials evaluated the efficacy and safety of Bimzelx in 1,480 adults with moderate-to-severe plaque psoriasis (search). Key findings from these studies include:
- Clear or Almost Clear Skin: More than eight out of 10 patients receiving Bimzelx (320 mg every four weeks) achieved PASI 90 (at least a 90 percent improvement in the Psoriasis Area & Severity Index) and IGA 0/1 (Investigator’s Global Assessment response of clear or almost clear skin) at week 16.
- Complete Skin Clearance: Approximately six out of 10 patients receiving Bimzelx (320 mg every four weeks) achieved PASI 100 (complete skin clearance) 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.
In the BE VIVID trial, patients treated with BIMZELX achieved superior levels of skin clearance at week 16, compared to those who received ustekinumab (p<0.0001). Similarly, in the BE SURE trial, Bimzelx demonstrated superiority over adalimumab (p<0.001) in achieving co-primary endpoints.
Dosage and Administration
The FDA-recommended dosage of Bimzelx for psoriasis patients is 320 mg, administered as two subcutaneous injections of 160 mg each, at Weeks 0, 4, 8, 12, and 16, followed by every 8 weeks thereafter. For patients weighing ≥120 kg, a dose of 320 mg every 4 weeks after week 16 may be considered. Bimzelx can be administered by a healthcare professional, or patients may self-inject after proper training. It is available as an autoinjector and a pre-filled syringe.
Safety Profile
The most common adverse reactions (≥ 1%) reported in clinical trials include upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Candida infections, and fatigue.
The prescribing information for Bimzelx includes warnings and precautions regarding suicidal ideation and behavior, infections, tuberculosis (search), liver biochemical abnormalities, inflammatory bowel disease (search), and the use of immunizations.
Psoriasis: A Significant Unmet Need
Psoriasis affects more than 7.5 million adults in the U.S. and impacts much more than the skin itself. In addition to skin symptoms such as itching and flaking, psoriasis can place strains on patients and their families, impacting work, relationships, and home lives. 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 (search) and the need for additional new treatment options.
Industry Impact
UCB (search) expects global peak sales for Bimzelx of at least €4 billion. The company plans to rapidly submit applications for additional indications in the U.S.
According to Jean-Christophe Tellier, CEO of UCB (search), this approval is part of an unprecedented series of product launches from UCB around the world, reflecting the company's scientific expertise, understanding of disease biology, and commitment to providing differentiated treatments.