European Medicines Agency recommends Bimzelx for hidradenitis suppurativa treatment
Click Here to Manage Email Alerts
Key takeaways:
- The committee’s positive opinion is based on results from phase 3 BE HEARD trials.
- If approved in the European Union, bimekizumab would be the first interleukin 17A and 17F inhibitor approved in this indication.
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorization for Bimzelx in the European Union and European Economic Area for hidradenitis suppurativa, UCB announced in a press release.
The recommendation for Bimzelx’s (bimekizumab, UCB) marketing authorization is for adult patients with moderate to severe HS that previously demonstrated inadequate responses to conventional systemic therapies. If the drug receives European Commission approval, it will be the first interleukin-17A and IL-17F inhibitor approved in the EU in this indication.
“The positive opinion from the [Committee for Medicinal Products for Human Use (CHMP)] represents a significant milestone toward bringing bimekizumab to people living with moderate to severe hidradenitis suppurativa, a chronic, painful inflammatory skin disease with limited treatment options,” Emmanuel Caeymaex, executive vice president of immunology solutions and head of U.S. solutions at UCB, said in the release. “If approved by the European Commission, this would represent the fourth marketing authorization for bimekizumab in 3 years, adding to the existing indications in moderate to severe plaque psoriasis, active psoriatic arthritis and active axial spondyloarthritis.”
The committee’s positive opinion is supported by data from two phase 3 trials, BE HEARD I and BE HEARD II. As previously reported by Healio, bimekizumab outperformed placebo in these trials, demonstrating an ability to clinically improve HS signs and symptoms at week 16 through week 48.
The European Commission will consider the CHMP’s positive opinion when deciding whether to grant the marketing authorization. If granted, the marketing authorization would be applicable to all EU member states and countries of the European Economic Area, according to the release.