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Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted marketing applications for UMB Pharmaceuticals' psoriasis treatment drug bimekizumab.
UCC is seeking approval in the United States and the European Union for the treatment of bimekizumab with moderate to severe plaque-like psoriasis.
approvals are based on data from the UCC Psoriasis Global Phase III Clinical Development Program.
Phase III studies reached the main endpoint: patients treated with bimekizumab had a higher rate of skin removal at the 16th week than those treated with placebo and AbbVie Humira.
addition, two studies have shown that bimekizumab is superior to existing biological therapies, including Janssen's Stelara and AbbVie's Humira.
In addition to being a treatment for psoriasis, UCB is currently studying bimekizumab as a potential treatment for psoriasis arthritis, hyperlinearthritis, non-radial axial spinal arthritis, and purulent sweat adenitis. "After a series of positive Phase III data, we are pleased to announce that the FDA and EMA have accepted our application to use bimekizumab as a potential new treatment for psoriasis," said Emmanuel Caeymaex, executive vice president of UMB at
UCB.
.
