Newest Psoriasis Treatment is Now Available

UCB has launched Bimzelx (bimekizumab-bkzx) to treat adults with moderate-to-severe plaque psoriasis. It is available as an autoinjector and a pre-filled syringe. The list price is $7,200 per syringe. The recommended dosage 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.

Commercially insured patients may be eligible to receive Bimzelx for $5 a dose. UCB will provide Bimzelx for $15 a dose for two 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.

Bimzelx is available through more than 20 specialty pharmacies, including CVS Specialty Pharmacy and Optum Specialty Pharmacy. A full list of the participating pharmacies can be found here.

Psoriasis affects more than 7.5 million adults in the United States and impacts much more than the skin itself. In plaque psoriasis, overactive immune cells produce too many proteins, causing plaques to form on the skin’s surface. Bimzelx is designed to selectively inhibit two key cytokines that drive inflammation – interleukin 17A (IL-17A) and interleukin 17F (IL-17F).

The FDA approved Bimzelex Oct. 17, 2023, based on data from three phase 3 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. 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 Bimzelx achieved clear or almost clear skin, with 59% to 68% achieving the goal of complete clearance.

Additionally, patients treated with Bimzelex achieved greater levels of skin clearance at week 16 compared with those who received Stelara (ustekinumab) in the BE VIVID trial and compared with Humira (adalimumab) 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.

Leah McCormick Howard

“The approval of bimekizumab will provide an important new treatment option for adults living with moderate-to-severe plaque psoriasis,” Leah McCormick Howard, J.D., president and CEO for the National Psoriasis Foundation, said in a press release 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.”

This story first appeared on Formulary Watch.