• 16 Oct 2024
• Admin
• News Article

US FDA Approves UCB’s 320 MG Single-Injection Device Presentations of Bimzelx

Overview

UCB, a global biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of Bimzelx (bimekizumab-bkzx).

Impact of New Presentations

These new device presentations add to the currently available 1 mL administration options, each containing 160 mg of bimekizumab-bkzx, and mean that patients requiring a 320 mg dose of bimekizumab-bkzx will have options for single-injection administration.

Statement from the CCO: UCB

• “Our goal with these single-injection regimens is to strengthen and expand administration options, increase convenience and enhance the individual patient experience,” said Emmanuel Caeymaex, executive vice president, head of patient impact, chief commercial officer, UCB. 
• “With the new device presentations, people with moderate-to-severe plaque psoriasis who receive a bimekizumab-bkzx maintenance dose of 320 mg will have the option of a single-injection every eight weeks.”

Behind the Approval 

• The approval of the 320 mg device presentations is supported by data from studies evaluating the bioequivalence of bimekizumab-bkzx 320 mg given as one 2 mL subcutaneous injection, and bimekizumab-bkzx 320 mg given as two 1 mL subcutaneous injections, in healthy study participants. 
• This is the second worldwide approval for the 320 mg single-injection administration options for bimekizumab-bkzx, following approval by the European Commission in August 2024.

Bimekizumab-bkzx Indication in US

• In the US, the indications for bimekizumab-bkzx where a 320 mg dose is recommended are adults with moderate-to-severe plaque psoriasis and adults with active psoriatic arthritis with coexistent moderate-to-severe plaque psoriasis. 
• In all other indications, adults with active psoriatic arthritis, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, and adults with active ankylosing spondylitis, a 160 mg dose is recommended.

Bimekizumab-bkzx Approvals

• In October 2023, bimekizumab-bkzx was first approved by the US FDA for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. 
• In September 2024, bimekizumab-bkzx was approved in the US for three new indications – the treatment of adults with active psoriatic arthritis, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation and adults with active ankylosing spondylitis.

What is Bimekizumab-bkzx?

• Bimekizumab-bkzx is a humanized IgG1 monoclonal antibody that selectively binds to IL-17A, IL-17F and IL-17AF cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex.
• Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin.

The Approved Indications

The Approved Indications for Bimekizumab in the Eu Are:

• Plaque psoriasis: Bimekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
• Psoriatic arthritis: Bimekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
• Axial spondyloarthritis: Bimekizumab is indicated for the treatment of adults with active non radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP), and/or magnetic resonance imaging (MRI), who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.
• Hidradenitis suppurativa: Bimekizumab is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy.

About the Company: UCB

UCB, Brussels, Belgium is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system.