UCB's Bimzelx Close To Challenging Major Psoriasis Players

Having generated a hefty package of positive data, including wins in head-to-head trials with psoriasis market leaders such as Novartis AG's Cosentyx and Johnson & Johnson’s Stelara, UCB S.A.'s bimekizumab is finally set to cross the finishing line after being recommended for approval by EU regulators for psoriasis.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for bimekizumab, the IL-17A and IL-17F inhibitor that the Belgian group will market as Bimzelx for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy. The recommendation is based on three Phase III studies – BE VIVID, BE READY and BE SURE – which all hit their co-primary and ranked secondary endpoints and showed that patients treated with bimekizumab achieved superior levels of skin clearance at week 16 compared with those who received AbbVie Inc