01 July 2021

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Global pharmaceutical company, UCB, recently announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion recommending approval of BIMZELX[®*] (bimekizumab), an investigational IL-17A and IL-17F inhibitor, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

The positive CHMP opinion is supported by data from three Phase 3 studies where bimekizumab demonstrated superior levels of skin clearance compared to placebo, ustekinumab and adalimumab.

The European Commission is expected to deliver its decision on the marketing authorisation of bimekizumab, under the trade name BIMZELX[®], in approximately two months. If approved, bimekizumab will be the first approved treatment for moderate to severe plaque psoriasis that selectively and directly inhibits both IL-17A and IL-17F.

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Reference
UCB Press Release