EMA accepts marketing authorization for bimekizumab for hidradenitis suppurativa

Key takeaways:

• If approved, this will be the fourth indication for bimekizumab in the EU.
• The application is supported by two phase 3 studies, BE HEARD I and BE HEARD II.

The European Medicines Agency has accepted for review the marketing authorization application for bimekizumab for moderate to severe hidradenitis suppurativa treatment in adults, UCB announced in a press release.

Bimekizumab is an interleukin (IL)-17A and IL-17F inhibitor that is currently approved in the European Union (EU) to treat numerous IL-17-mediated diseases including plaque psoriasis, axial spondyloarthritis and psoriatic arthritis.

“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,” Emmanuel Caeymaex, executive vice president of immunology and U.S. solutions at UCB, said in the release. “If approved, this would represent the fourth indication for bimekizumab in the European Union across a range of IL-17 mediated diseases.”

Data from the phase 3 studies, BE HEARD I and BE HEARD II, were used to support this application.

All endpoints from the studies were met, according to the press release, with bimekizumab exhibiting statistically significant improvements compared with placebo in the proportion of subjects who achieved at least a 50% reduction or a 75% reduction from baseline in total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count, at week 16. This response was maintained through week 48.

Although the studies showed a consistent safety profile for the drug, bimekizumab’s safety and efficacy is not yet established as the drug is not approved for use in HS by any regulatory authority worldwide, according to the press release.