FDA Approves Single-Injection 320 mg BIMZELX® for Plaque Psoriasis and Psoriatic Arthritis
核心洞察
The FDA has approved 320 mg single-injection devices (pre-filled syringe and autoinjector) of BIMZELX® (bimekizumab-bkzx) for specific patient groups.
These new options provide convenience for patients needing a 320 mg maintenance dose, allowing for a single injection every eight weeks.
The approval was based on bioequivalence studies comparing single 2 mL injections to two 1 mL injections of bimekizumab-bkzx.
UCB (搜索)'s BIMZELX® (bimekizumab-bkzx) has received FDA approval for new 320 mg single-injection device presentations, including a 2 mL pre-filled syringe and autoinjector. This approval, announced on October 14, 2024, offers a more convenient administration option for patients requiring a 320 mg dose, specifically those with moderate-to-severe plaque psoriasis (搜索) and active psoriatic arthritis (搜索) with coexistent moderate-to-severe plaque psoriasis. These new options will be available in the U.S. in Q1 2025.
This approval expands the existing administration options, which include 1 mL pre-filled syringes and autoinjectors containing 160 mg of bimekizumab-bkzx. The single-injection regimen aims to enhance the patient experience by reducing the number of injections required.
Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, Chief Commercial Officer, UCB (搜索), stated, “Our goal with these single-injection regimens is to strengthen and expand administration options, increase convenience and enhance the individual patient experience. With the new device presentations, people with moderate-to-severe plaque psoriasis (搜索) who receive a bimekizumab-bkzx maintenance dose of 320 mg will have the option of a single-injection every eight weeks.”
Clinical Support for Approval
The FDA's decision was supported by data from studies assessing the bioequivalence of bimekizumab-bkzx 320 mg administered as a single 2 mL subcutaneous injection compared to two 1 mL subcutaneous injections in healthy participants. The European Commission approved the 320 mg single-injection administration options in August 2024.
Indications and Dosing
Bimekizumab-bkzx is indicated in the U.S. for adults with moderate-to-severe plaque psoriasis (搜索) and adults with active psoriatic arthritis (搜索) with coexistent moderate-to-severe plaque psoriasis, where a 320 mg dose is recommended. For other indications, such as active psoriatic arthritis without plaque psoriasis, active non-radiographic axial spondyloarthritis (搜索), and active ankylosing spondylitis (搜索), a 160 mg dose is recommended.
The recommended dosage for plaque psoriasis (搜索) and psoriatic arthritis (搜索) with coexistent plaque psoriasis is 320 mg at Weeks 0, 4, 8, 12, and 16, followed by every 8 weeks thereafter. For patients weighing 120 kg or more, a dosage of 320 mg every 4 weeks after Week 16 should be considered.
About Bimekizumab
Bimekizumab-bkzx is a humanized IgG1 monoclonal antibody that selectively binds to IL-17A, IL-17F (搜索), and IL-17AF (搜索) cytokines, preventing their interaction with the IL-17RA/IL-17RC receptor complex. Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin.
Safety Information
Bimekizumab-bkzx carries warnings and precautions regarding suicidal ideation and behavior, infections (including tuberculosis (搜索)), liver biochemical abnormalities, inflammatory bowel disease (搜索), and the use of live vaccines. Common adverse reactions in plaque psoriasis (搜索) include upper respiratory tract infections, oral candidiasis, and headache. In psoriatic arthritis (搜索), common adverse reactions include upper respiratory tract infections, oral candidiasis, and diarrhea.