FDA Approves Bimekizumab for Moderate-to-Severe Plaque Psoriasis 

The U.S. Food and Drug Administration (FDA) has approved BIMZELX® (bimekizumab-bkzx) for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It is the first and only approved IL-17A and IL-17F inhibitor for this indication.

plaque psoriasis

Bimekizumab’s approval comes after data from three Phase 3, multicenter, randomized, trials (BE READY, BE VIVID, and BE SURE) which evaluated the efficacy and safety of bimekizumab in 1,480 adults with moderate-to-severe plaque psoriasis.

Investigators noted a number of key findings across all studies. This included:

  1. Clear or Almost Clear Skin: More than 8 out of 10 patients receiving bimekizumab (320 mg every four weeks [Q4W]) achieved PASI 90 and IGA 0/1 at week 16.
  2. Complete Skin Clearance: Approximately 6 out of 10 patients receiving bimekizumab (320 mg Q4W) achieved PASI 100 at week 16.
  3. Speed of Response: Clinical responses achieved with bimekizumab were rapid, with more than 7 out of 10 patients achieving PASI 75 at week 4 following one dose (320 mg).
  4. Maintenance of Response: Clinical responses achieved with bimekizumab 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 bimekizumab treatment.

The most common adverse reactions noted in the trials were upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Candida infections, and fatigue.

The FDA has recommended the dosage of bimekizumab for psoriasis patients be 320 mg (given as two subcutaneous injections of 160 mg each) at weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For those patients weighing ≥120 kg, a dose of 320 mg every 4 weeks after week 16 may be considered.

Bimekizumab will be available as an autoinjector and a pre-filled syringe. It can be administered by a healthcare professional, or a patient may self-inject after they receive proper training. Bimekizumab is expected to be available in the U.S. in approximately one month.

According to Leah McCormick Howard, J.D., President and CEO of the National Psoriasis Foundation, “The approval of bimekizumab will provide an important new treatment option for adults living with moderate to severe plaque psoriasis. Our hope is that new treatments translate into improved outcomes for many and help alleviate the physical and emotional burden of psoriasis.”

With the ever-evolving treatment landscape in psoriasis as well as other skin conditions, providers must remain abreast of the latest therapies and how best to implement these into their practice. Be sure not to miss our 2024 South Beach Symposium meeting this Feb. 8-11 in Miami Beach where you can learn more about the latest developments in both medical and aesthetic dermatology.


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