European Commission grants Bimzelx marketing authorization for hidradenitis suppurativa
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Key takeaways:
- This approval marks bimekizumab’s fourth indication within the European Union.
- Data from the phase 3 BE HEARD trials contributed to marketing authorization approval.
The European Commission has granted marketing authorization for Bimzelx to treat adults with active moderate to severe hidradenitis suppurativa, according to a UCB press release.
Following the positive opinion issued by the European Medicine Agency’s Committee for Medicinal Products for Human Use in March, the marketing authorization for Bimzelx (bimekizumab, UCB) is for adults with moderate to severe HS who displayed an inadequate response to conventional systemic HS therapy.
“We are proud to bring the first and only approved medicine targeting [interleukin]-17A and IL-17F to the hidradenitis suppurativa community. We believe that bimekizumab has the potential to transform care for people living with moderate to severe disease,” Emmanuel Caeymaex, executive vice president of immunology solutions and head of U.S. solutions at UCB, said in the release.
The approval, which marks the fourth approved indication for bimekizumab in the European Union, was based on results from two phase 3 studies, BE HEARD I and BE HEARD II, in which a significantly higher proportion of patients treated with bimekizumab vs. placebo achieved the primary endpoint of a Hidradenitis Suppurativa Clinical Response score of 50 at week 16.
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