BioCentury
ARTICLE | Clinical News

Careram regulatory update

December 7, 2015 8:00 AM UTC

Eisai and Toyama said Japan lifted the condition for approval of Careram/Kolbet iguratimod to treat rheumatoid arthritis. In June 2012, Japan approved the product on the condition that a “use-results survey” was conducted and efficacy and safety data were gathered on all treated patients until “adequate data from a certain number of cases” were collected. Iguratimod is an oral DMARD that inhibits the production of IL-1, IL-6, IL-8 and tumor necrosis factor (TNF). ...