EC Approves UCB’s Treatment for Moderate-to-Severe Plaque Psoriasis

The European Commission has approved UCB's treatment for adults with moderate-to-severe plaque psoriasis, BIMZELX (bimekizumab).

Global biopharmaceutical company, UCB, announced on Aug. 24, 2021, that the European Commission (EC) has approved its treatment for adults with moderate-to-severe plaque psoriasis, BIMZELX (bimekizumab). The treatment will now be available for eligible patients throughout the European Union and Iceland, Liechtenstein, and Norway.

Bimekizumab has been designed to selectively and directly inhibit two key cytokines, IL-17A and IL-17F, that drive inflammation in plaque psoriasis. The approved recommended dose of the therapy is 320 mg, which is to be administered via two subcutaneous injections every four weeks to 16 weeks, and then every eight weeks thereafter.

“The approval of BIMZELX in Europe is the first marketing authorization for this new psoriasis treatment worldwide and represents a landmark moment for the dermatology community and UCB,” said Emmanuel Caeymaex, executive vice-president, Immunology Solutions and Head of US, UCB, in the press release. “Our ambition is to transform the lives of people living with severe diseases, and we are incredibly proud to bring a new treatment option to people living with moderate to severe plaque psoriasis in Europe. We believe that bimekizumab has the potential to raise expectations of what psoriasis treatment can deliver.”

“In the pivotal Phase III studies patients treated with bimekizumab achieved superior levels of skin clearance compared to those treated with placebo, adalimumab, and ustekinumab, and in the Phase IIIb study, treatment with bimekizumab resulted in greater levels of skin clearance than secukinumab. Across studies, about 60 percent of bimekizumab-treated patients achieved complete skin clearance at week 16, and this response was maintained for up to a year,” added Richard Warren, Salford Royal NHS Foundation Trust and The University of Manchester, UK, in the press release. “The approval of bimekizumab in the EU provides a welcome new treatment option that may help more patients with moderate to severe plaque psoriasis to achieve their treatment goals.”

Source: UCB