FDA Approves BIMZELX for Psoriasis

FDA Approves BIMZELX for Psoriasis

October 19, 2023
Susan Jara

Adults living with moderate to severe plaque psoriasis, a chronic autoimmune skin condition characterized by raised, reddish, and scaly patches on the skin’s surface, now have a new treatment option. On October 18, the U.S. Food and Drug Administration (FDA) greenlighted BIMZELX (bimekizumab-bkzx) for the treatment of this condition.

BIMZELX is the first of its kind, designed to selectively inhibit two key cytokines driving inflammatory processes. Produced by the global biopharmaceutical company UCB, bimekizumab belongs to a group of medications called biologics. It is designed to help adults with moderate to severe plaque psoriasis, especially those who might need systemic therapy (like a pill or injection/infusion) or phototherapy.

The injectable drug works by targeting two significant substances in your body known as interleukin 17A (IL-17A) and interleukin 17F (IL-17F), both of which play a role in causing inflammation in our bodies.

“IL-17A has been recognized for a longer period of time but more recent cutting-edge science has really brought to our attention and highlighted the role of IL-17F, which is a significant contributor to inflammation in various diseases including plaque psoriasis, hidradenitis suppurativa (HS), and psoriatic arthritis,” explains Jeffrey Stark, MD, Vice President and Head of Medical Immunology at UCB. “We know that IL-17F works along IL-17A in driving that inflammation and there are benefits of controlling both of those cytokines to reduce the inflammation and improve disease control. We are excited about a treatment strategy that enables us to inhibit a broader spectrum of the inflammation that’s driving these diseases.”

The approval of bimekizumab was based on the results of Phase 3/3b trials, where bimekizumab showed superior performance in clearing the skin compared to a placebo and three other existing psoriasis biologics within 16 weeks. According to the trials, seven out of 10 patients achieved PASI 75 at week four, following one dose (320 mg). “At week 16, 85-91 percent of patients treated with bimekizumab achieved clear or almost clear skin, with 59-68 percent achieving the goal of complete clearance,” noted Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB, in a company press release.

PASI stands for Psoriasis Area and Severity Index; achieving PASI 75 means that a patient has had a 75 percent or greater improvement from baseline.

“We have come along way over the years from talking about PASI 50 responses — 50 percent of improvement — to the point that we are now in the BIMZELX trials and are talking about PASI 90 and PASI 100 responses, representing complete skin clearance,” says Dr. Stark. “It’s a threshold we want all of these patients to achieve because we know it makes such a difference in their quality of life and sense of well-being as they deal with the challenges of psoriasis.”

These great improvements were not only rapid but also long-lasting, persisting for up to a year. Long-term data revealed that the majority of patients continued to benefit from bimekizumab for up to three years. Less than one percent of patients experienced negative reactions, including upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Candida infections, and fatigue.

BIMZELX is expected to be available in about one month. The FDA-recommended dose of bimekizumab for psoriasis patients is 320 mg. This is administered as two subcutaneous injections of 160 mg each. The injections are given at Weeks 0, 4, 8, 12, and 16, and then continue every 8 weeks thereafter. Patients will be able to receive this medication either through administration by a health care provider or by self-injection after receiving proper training from a health care provider.

What This Means for You

Living with a visible, systemic skin condition like psoriasis can be quite challenging, both emotionally and physically. However, the good news is that there are now advanced treatments available, providing you with a better chance of finding one that can address not only the physical aspects of the condition but also provide relief for the emotional toll it may take.

“Even though the disease is very visible, some of the areas that it can involve that are less visible can be equally impactful,” says Dr. Stark. “We think about patients who live with scalp psoriasis. It’s a little more hidden under the hair, but from a quality-of-life standpoint, it really interferes with people leading the type of life they want to lead. The other is genital psoriasis where, again, a hidden area but from a quality-of-life standpoint the impact on patients is profound.”

The availability of more treatment options will provide greater opportunity to find a drug that improves your symptoms and matches your overall goals for managing psoriasis. We always encourage you to have a “heart-to-heart” conversation with your doctor about selecting the right medication for you. Consider factors like your medical history and your treatment preferences (whether it’s pills, injections, or infusions). This collaborative approach can lead to a more effective and tailored treatment plan, improving your quality of life while managing your psoriasis.

Powerful Podcasts to Help You Live Better with Psoriasis

The Global Healthy Living Foundation is embracing audio storytelling as part of our mission to reach the chronic disease patient community where they are. Click here to listen to one of our many podcasts, including Getting Clear on Psoriasis, The Psoriatic Arthritis Club, Breaking Down Biosimilars, The Health Advocates, Patient PrepRheum, Talking Head Pain, MatterofVax, Gut Culture, and more.




BIMZELX (bimekizumab) U.S. Prescribing Information. October 2023. https://www.ucb-usa.com/Innovation/Products/Bimzelx.

Gordon KB, et al. Bimekizumab efficacy and safety in moderate-to-severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021. doi: https://doi.org/10.1016/S0140-6736(21)00126-4.

Interview with Jeffrey Stark, MD, Vice President and Head of Medical Immunology at UCB.

Reich K, et al. Bimekizumab versus ustekinumab for the treatment of moderate-to-severe plaque psoriasis (BE    VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo-controlled phase 3 trial. Lancet. 2021. doi: https://doi.org/10.1016/S0140-6736(21)00125-2.

U.S. Food and Drug Administration. Novel Drug Approvals for 2023.  https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214958Orig1s000ltr.pdf. 



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