Bimzelx® (bimekizumab-bkzx – UCB) injection was approved by the U.S. Food and Drug Administration (FDA) on Oct. 18, 2023. It blocks the activity of interleukins (IL) 17A and 17F for treating adults who have moderate to severe plaque psoriasis that will respond to systemic therapy or phototherapy. Dosing is 320mg (two subcutaneous [SC] injections at the same time) spaced four weeks apart for the first five treatments. Then the schedule for most patients shifts to once every eight weeks. The launch is planned within one month, but pricing and distribution plans presently are unknown. Prescribing information is here.
At a Glance
- Brand (Generic) Name: Bimzelx (bimekizumab-bkzx)
- Manufacturer: UCB
- Date Approved: Oct. 18, 2023
- Indication: the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
- Dosage Forms Available: single-dose prefilled syringes and auto-injectors that contain 160mg of Bimzelx
- Launch Date: November 2023
- Estimated Annual Cost: Not yet known
- Psoriasis is an autoimmune disease that involves excessive activity of the immune system. It causes skin cells to grow much faster than normal. As a result, cells build up on the skin’s surface as large, raised spots (plaques). In addition to itchy, painful, red skin, patients who have psoriasis also may experience internal organ damage due to inflammation.
- According to the National Psoriasis Foundation, an estimated 7.5 million American adults have some degree of psoriasis.
- Usually showing symptoms when patients are between 15 years and 25 years of age, psoriasis is slightly more common among Caucasians than among other ethnic groups and it affects about equal numbers of men and women.
- Bimzelx blocks IL-17A and IL-17F to interrupt inflammation associated with psoriasis.
- In clinical trials, up to 91% of patients using Bimzelx had clear or nearly clear skin compared to placebo at 16 weeks. Responses began as early as week four for some patients and lasted as long as three years for many study participants.
- The most reported side effects included acne, fatigue, headache, gastroenteritis, and injection site reactions.
- Patients using Bimzelx also were more susceptible to bacterial, fungal, viral, and other infections, including tuberculosis (TB). All patients should be tested for TB before starting it.
- Multiple other injected, oral, and topical drugs, including biologics such as adalimumab (Humira® and biosimilars), Enbrel® (etanercept), and Skyrizi® (risankizumab), are FDA-approved to treat psoriasis.