EC approves UCB’s plaque psoriasis treatment
pharmafile | August 24, 2021 | News story | Manufacturing and Production |
UCB announced on Tuesday that the European Commission (EC) has granted marketing authorisation for Bimzelx (bimekizumab) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Bimekizumab is the first approved treatment in the European Union for moderate to severe plaque psoriasis that is designed to selectively and directly inhibit both IL-17A and IL-17F, two key cytokines driving inflammatory processes.
The approval of Bimzelx in Europe is the first marketing authorisation for this new psoriasis treatment worldwide and represents a landmark moment for the dermatology community and UCB.
“We believe that bimekizumab has the potential to raise expectations of what psoriasis treatment can deliver.” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of US, UCB.
Bimekizumab is approved at a recommended dose of 320 mg, administered by two subcutaneous injections every four weeks to week 16 and every eight weeks thereafter. For some patients with a body weight ≥120 kg who did not achieve complete skin clearance at week 16, 320 mg every 4 weeks after week 16 may further improve treatment response.
Professor Richard Warren, Salford Royal NHS Foundation Trust and The University of Manchester, said: “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.
The approval from the EC is valid in all 27 member states of the EU, as well as Iceland, Liechtenstein, and Norway. Bimekizumab is currently under review by the FDA for the treatment of adults with moderate to severe plaque psoriasis. Regulatory reviews are also underway in Australia, Canada, Great Britain, and Japan.
Kat Jenkins
