UCB Receives Approval from the EMA for its Treatment against Hidradenitis Suppurativa

The European Medicines Agency (EMA), one step closer to granting authorization to a new UCB treatment. The Belgian biopharmaceutical company has obtained a positive assessment from the Committee for Medicinal Products for Human Use (Chmp) of the EMA for the marketing of Bimzelx, a compound with which to treat hidradenitis suppurativa in adult patients who respond inadequately to conventional treatments.

If approved by the European Commission, this drug will be the first IL-17A and IL-17F inhibitor approved in the European Union (EU) to treat hidradenitis suppurativa. It is a chronic inflammatory skin pathology that is expressed in the form of abscesses, fistulas with pus secretion and nodules, generally in the armpits, groin and buttocks. It affects 1% of the population in almost all countries in which there are studies.

“If approved by the European Commission, it would be the fourth marketing authorization for this treatment in the last three years and would be added to the existing indications that the therapy already has for moderate to severe plaque psoriasis.” , active psoriatic arthritis and active axial spondyloarthritis,” Emmanuel Caeymaex, executive vice president of Immunology and director in the United States of UCB, states in a company statement.

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UCB has had 1,014 participants diagnosed with hidradenitis suppurativa to test its medication

The positive resolution of the Chmp on Bimzelx against hidradenitis suppurativa is based on the findings of the phase III studies Be Heard I and Be Heard II, in which the efficacy and safety of the treatment in adults with the aforementioned disease was evaluated. The data reflect that UCB treatment, compared to placebo, resulted in significant improvements in hidradenitis suppurativa symptoms at week sixteen , which was considered the primary endpoint in the study. Furthermore, responses lasted until week 48.

Be Heard I and Be Heard II are phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of the Belgian pharmaceutical compound in adults with moderate to severe hidradenitis suppurativa. . The two studies had 1,014 diagnosed participants .

UCB is a biopharmaceutical company that has nearly 9,000 employees in forty countries, in addition to revenues of €5.3 billion in 2023.

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