If approved, hidradenitis suppurativa would be the 4th indication for the drug within the European Union.
Global biopharmaceutical company UCB announced1 today its regulatory submission to the European Union (EU) for bimekizumab to treat hidradenitis suppurativa (HS). This follows the European Medicines Agency’s acceptance of UCB’s marketing authorization application for the drug.
This action comes after positive data stemming from the BE HEARD I and BE HEARD II studies. Both phase 3 studies evaluated the safety and efficacy of bimekizumab in a cohort of adult patients (n=505 in BE HEARD I; n=509 in BE HEARD II) with moderate to severe HS.
At as early as week 16 in the 48-week study period, a higher portion of patients being treated with bimekizumab achieved the study’s primary endpoint of Hidradenitis Suppurativa Clinical Response, HiSCR50, compared to patients being treated with the placebo in both BE HEARD I and BE HEARD II. Statistical significance was achieved in BE HEARD II among patients receiving bimekizumab Q4.
Additionally, patients receiving bimekizumab achieved deep levels of clinical response through the achievement of HiSCR75, which served as a secondary endpoint of the study. Furthermore, at week 16, patients receiving bimekizumab versus the placebo achieved improvements in their overall health-related quality of life when compared to baseline scoring.
Data from the studies was presented at the 2023 American Academy of Dermatology Annual Meeting in New Orleans, Louisiana.
In August 2021, bimekizumab received marketing authorization throughout the EU for the treatment of moderate to severe plaque psoriasis in adult patients. Earlier this summer, the drug was also approved in the EU to treat active psoriatic arthritis and active axial spondyloarthritis in adult populations.
Currently, bimekizumab has not been approved by any regulatory agency for use in patients with HS.
“This EU regulatory submission for bimekizumab reflects our pursuit to address unmet patient needs and to advance standards of care in hidradenitis suppurativa, especially given that few treatment options are available today,” said Emmanual Caeymaex in the press release. Caeymaex is executive vice president of immunology solutions and head of US at UCB.
“If approved, this would represent the fourth indication for bimekizumab in the European Union across a range of IL-17 mediated diseases,” he said.