FDA approves first subcutaneous version of blockbuster IBD drug infliximab

The FDA on Sun­day ap­proved Cell­tri­on’s Zym­fen­tra (in­flix­imab-dyyb), which is the first sub­cu­ta­neous ver­sion of the block­buster bi­o­log­ic, as main­te­nance ther­a­py for in­flam­ma­to­ry bow­el dis­ease.

The ap­proval is based on pos­i­tive da­ta from two Phase III tri­als that as­sessed the ef­fi­ca­cy of Zym­fen­tra as main­te­nance ther­a­py in pa­tients with mod­er­ate to se­vere ul­cer­a­tive col­i­tis and Crohn’s dis­ease. The com­pa­ny said the tri­als demon­strat­ed su­pe­ri­or­i­ty in the pri­ma­ry end­points of clin­i­cal re­mis­sion and en­do­scop­ic re­sponse com­pared to place­bo as main­te­nance ther­a­py af­ter in­duc­tion ther­a­py of in­tra­venous for­mu­la­tion of in­flix­imab in pa­tients with UC and Crohn’s, over a 54-week pe­ri­od.

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