The approval is based on results from three Phase 3 clinical trials in which antibody delivered fast, complete and lasting levels of skin clearance for up to one year and was generally well-tolerated
FDA has approved UCB’s Bimzelx for plaque psoriasis. (Credit: UCB S.A.)
UCB has obtained the US Food and Drug Administration (FDA) approval for Bimzelx (bimekizumab-bkzx) to treat moderate to severe plaque psoriasis adults who are candidates for systemic therapy or phototherapy.
Available as an autoinjector and a pre-filled syringe, Bimzelx is a humanised IgG1 monoclonal antibody.
It is designed to selectively bind to interleukin 17A (IL-17A), interleukin 17F (IL-17F), and interleukin 17AF (IL-17AF) cytokines, preventing their interaction with the IL-17RA/IL-17RC receptor complex.
The approval is based on results from BE READY, BE VIVID, and BE SURE Phase 3, multi-centre, randomised, placebo, and/or active comparator-controlled trials.
These late-stage trials assessed the safety and efficacy of Bimzelx in 1,480 adults with moderate to severe plaque psoriasis.
BE VIVID evaluated Bimzelx against placebo and ustekinumab, BE READY against placebo, and BE SURE evaluated the drug against adalimumab.
According to the results, the studies met their co-primary endpoints, and all ranked secondary endpoints.
Bimekizumab-treated patients achieved superior levels of skin clearance at week 16, in comparison to those who were administered with ustekinumab, placebo, and adalimumab.
The results were measured by at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) and an Investigator’s Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1).
Out of 10 patients receiving Bimzelx, eight of them achieved PASI 90 and IGA 0/1 at week 16. Around six out of 10 patients getting bimekizumab achieved PASI 100 at week 16.
The monoclonal antibody delivered fast, complete and lasting levels of skin clearance for up to one year and was generally well tolerated, the Belgian biopharmaceutical firm said.
UCB US Immunology Solutions Head and EVP Emmanuel Caeymaex said: “Today’s FDA approval for Bimzelx is an exciting milestone that reflects our commitment to continuously improving the standard of care in plaque psoriasis and to raising expectations of what treatment can deliver.
“We know that completely clear skin is valued by people with psoriasis and, in our Phase 3 trials, at week 16, 85-91% of patients treated with bimekizumab achieved clear or almost clear skin, with 59-68% achieving the goal of complete clearance.”
Bimzelx is expected to be available in the US in about one month.