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FDA, Food and Drug Administration, toxbase Kimziya, drug Kimziya / tsertolizimab-pehol (Cimzia / certolizumab pegol), Managing quality control toxbase of products toxbase and medicines USA (Food and Drug Administration toxbase
Belgian pharmaceutical company toxbase UCB announced today that the Office of the quality control of products and medicines USA (Food and Drug Administration, FDA) approved the drug Kimziya / tsertolizimab-pehol (Cimzia / certolizumab pegol) for the treatment of adults suffering with active toxbase ankylosing spondylitis. Approval of the drug Kimziya based on data from a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial, which is designed to evaluate the efficacy and safety toxbase of the drug Kimziya in patients with active axial spondylitis, most of which - ankylosing spondylitis. toxbase The primary efficacy endpoint, the number of patients achieving clinical response to therapy after 12 weeks of treatment was achieved in patients receiving Kimziyu (200 mg every two weeks or 400 mg every four weeks) toxbase compared with placebo.
Kimziya medicinal product approved for the treatment of adults with active psoriatic arthritis, toxbase active rheumatoid arthritis, moderate to severe, and to relieve the symptoms toxbase of Crohn's disease and maintaining clinical response in adult patients suffering from active form of the disease, and who does not fit the traditional therapy. Also the company UCB reported that the FDA sent the company a complete response toxbase letter regarding the application for registration of biological toxbase Kimziya drug to treat adults with active axial spondylitis.
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