FDA approves Bimzelx for treatment of moderate to severe plaque psoriasis
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Key takeaways:
- Bimzelx (bimekizumab-bkzx) is the first and only interleukin 17A and 17F inhibitor approved in this indication.
- The approval is indicated for systemic therapy candidates with moderate to severe plaque psoriasis.
The FDA has approved Bimzelx for moderate to severe plaque psoriasis treatment in adults who are eligible for systemic therapy or phototherapy, UCB announced in a press release.
“While gaining completely clear skin has been shown to considerably reduce the negative impact psoriasis has on quality of life, many people living with the disease do not achieve complete or almost complete skin clearance with their current therapy,” Emmanuel Caeymaex, executive vice president of immunology solutions and head of U.S. solutions at UCB, told Healio. “We believe Bimzelx will make a true and meaningful difference in the lives of people living with psoriasis in the U.S.”
The approval of Bimzelx (bimekizumab-bkzx) makes it the first and only psoriasis treatment that selectively inhibits interleukin (IL) 17A and 17F, according to the press release.
Recommended dosage for Bimzelx is 320 mg, dosed as two subcutaneous 160 mg injections, at weeks 0, 4, 8, 12 and 16 followed by once every 8 weeks moving forward. If patients weigh 120 kg or more, the 4-week dosing schedule after week 16 may be continued.
The drug’s approval was supported by data from three phase 3 trials: Be READY, BE VIVID and BE SURE. These studies evaluated the efficacy and safety of Bimzelx in more than 1,400 patients with moderate to severe plaque psoriasis.
Results from these studies showed that Bimzelx elicited higher levels of skin clearance at week 16 compared with placebo, ustekinumab and adalimumab. According to the press release, more than eight out of 10 people receiving Bimzelx achieved PASI 90 and IGA 0/1 by week 16 and approximately six out of 10 achieved PASI 100.
Bimzelx boasted rapid responses with more than seven of 10 patients achieving PASI 75 as early as week 4. Further, the positive responses that were achieved at week 16 proved to be sustained up to 1 year.
The most common adverse reactions, occurring in 1% or more of patients, included upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other Candida infections and fatigue.
“We are proud that Bimzelx is now approved in the U.S.,” Caeymaex said.
Perspective
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The approval of Bimzelx represents a new frontier in what dermatologists can offer patients with moderate to severe psoriasis. It appears to be the most rapid acting and highest efficacy treatment option for moderate to severe psoriasis to date.
That said, it is a novel biologic targeting IL-17A and IL-17F. The FDA has given it warnings for suicidal ideation and behavior (1.8% of Bimzelx patients vs. 0.6% of placebo patients), infections (36% of Bimzelx patients vs. 23% of placebo patients). The FDA also recommends testing liver enzymes at baseline and according to routine management and warns against using Bimzelx in patients with active tuberculosis or active inflammatory bowel disease.
Nevertheless, serious side effects are quite uncommon with Bimzelx and it is very well tolerated; although compared with other biologics, mucocutaneous Candida infections are quite common and clinicians will need to be prepared to identify and treat this infection.
I am looking forward to treating my patients with psoriasis who have been recalcitrant to other biologics with Bimzelx.
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