Bimekizumab-bkzx, the Newest Psoriasis Treatment, Is Now Available

This article was originally published on Formulary Watch^®. It has been lightly edited.

Psoriasis skin, eczema, rash and other skin diseases. A woman hides her face, she is ashamed of her autoimmune genetic disease. Imperfect beauty. | Image credit: stockmaster - stock.adobe.com.jpg

UCB announced it has launched bimekizumab-bkzx (Bimzelx) to treat adults with moderate-to-severe plaque psoriasis.

Psoriasis affects more than 7.5 million adults in the United States and impacts much more than the skin itself. In addition to the recognized skin symptoms such as itching and flaking, psoriasis can place strains on patients and their families, impacting work. In plaque psoriasis, overactive immune cells produce too many proteins, causing plaques to form on the skin’s surface.

Bimekizumab-bkzx is designed to selectively inhibit 2 key cytokines that drive inflammation—interleukin 17A (IL-17A) and interleukin 17F (IL-17F).

The FDA approved the drug on October 17, 2023, based on data from 3 phase 3 trials (BE READY, BE VIVID, and BE SURE), which evaluated the efficacy and safety of the drug in 1480 adults with moderate-to-severe plaque psoriasis. All studies met their co-primary endpoints and all ranked secondary endpoints.

In the phase 3 trials, at week 16, 85% to 91% of patients treated with bimekizumab-bkzx achieved clear or almost clear skin, with 59% to 68% achieving the goal of complete clearance.

Additionally, patients treated with bimekizumab-bkzx achieved greater levels of skin clearance at week 16 compared with those who received ustekinumab (Stelara) in the BE VIVID trial, and compared with adalimumab (Humira) in the BE SURE trial. The most common adverse reactions are upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other Candida infections, and fatigue.

“The approval of bimekizumab will provide an important new treatment option for adults living with moderate-to-severe plaque psoriasis,” said Leah McCormick Howard, JD, president and CEO for the National Psoriasis Foundation, in a press release¹ when the therapy was approved. “Our hope is that new treatments translate into improved outcomes for many and help alleviate the physical and emotional burden of psoriasis.”

It is available as an autoinjector and a pre-filled syringe. The list price is $7200 per syringe.² The recommended dosage is 320 mg (given as 2 subcutaneous injections of 160 mg each) at weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter.

Commercially insured patients may be eligible to receive bimekizumab-bkzx for $5 a dose. UCB will provide bimekizumab-bkzx for $15 a dose for 2 years if insurance coverage is delayed or denied. The company indicates that this assistance is for the benefit of patients and “is intended to be credited in full toward patient out-of-pocket obligations and maximums, including applicable co-payments, coinsurance, and deductibles." Patients also have access to a nurse navigator. Furthermore, bimekizumab-bkzx is available through more than 20 specialty pharmacies, including CVS Specialty Pharmacy and Optum Specialty Pharmacy.³

References

1. Bimzelx approved by the US FDA for the treatment of adults with moderate-to-severe plaque psoriasis. UCB. October 18, 2023. Accessed November 30, 2023. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/bimzelx-approved-by-the-us-fda-for-the-treatment-of-adults-with-moderate-to-severe-plaque-psoriasis

2. How much should I expect to pay for bimzelx (bimekizumab-bkzx)? UCB. Accessed November 30, 2023. https://www.ucb-usa.com/Sustainability/Affordability/Bimzelx-Pricing-Info#:~:text=Prescription%20drug%20prices%20can%20be,your%20prescription%20drug%20insurance%20plan

3. UCB is committed to helping your patients with quick access to therapy through any specialty pharmacy. UCB. Accessed November 30, 2023. https://www.bimzelxhcp.com/specialty-pharmacy-flashcard.pdf