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FDA and EMA have accepted the biologics license application and marketing authorization application, respectively, for bimekizumab.
Global biopharmaceutical company, UCB, has announced that the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted the biologics license application (BLA) and marketing authorization application (MAA), respectively, for bimekizumab.
In a Sept. 22, 2020 press release, the company revealed that the application submissions have been accepted for the investigational humanized monoclonal IgG1 antibody, bimekizumab, to be used as a treatment for adults with moderate to severe plaque psoriasis. The applications were based on data from a global Phase III clinical development program.
“After a series of positive Phase III data readouts, we are delighted to announce that the US FDA and EMA have accepted our applications to file bimekizumab as a potential new treatment for psoriasis,” said Emmanuel Caeymaex, executive vice-president Immunology Solutions and head of US, UCB, in the press release. “This milestone brings us one step closer to being able to offer a meaningful new treatment option for people living with this debilitating disease. UCB is committed to providing innovative solutions for people living with serious inflammatory diseases like psoriasis.”
Evaluation of the safety and efficacy of bimekizumab are still ongoing and the drug is not yet approved by any regulatory authority worldwide. The drug is also under evaluation for potential indications in psoriatic arthritis.