FDA to re­view Takeda's BLA re­sub­mis­sion for sub­cu­ta­neous UC drug En­tyvio af­ter 2019 re­jec­tion

Take­da has re­filed a bi­o­log­ics li­cense ap­pli­ca­tion for its sub­cu­ta­neous ver­sion of the block­buster ul­cer­a­tive col­i­tis drug En­tyvio fol­low­ing an FDA re­jec­tion in 2019, the com­pa­ny an­nounced to­day.

The com­pa­ny ex­pects a de­ci­sion by the end of the year.

En­tyvio was first ap­proved in 2014 as an in­tra­venous for­mu­la­tion to treat ul­cer­a­tive col­i­tis and Crohn’s dis­ease, and Take­da last fall raised its peak sales es­ti­mates for the drug to $7.5 bil­lion to $9 bil­lion. How­ev­er, the FDA is­sued a CRL to the com­pa­ny’s sub­cu­ta­neous ver­sion in 2019 over is­sues re­lat­ed to the de­sign and la­bel­ing of the de­vice, Take­da said. The com­pa­ny spec­i­fied that the CRL was not a re­sult of safe­ty or ef­fi­ca­cy da­ta, and was al­so un­re­lat­ed to the IV for­mu­la­tion of the drug and con­clu­sions from the VIS­I­BLE 1 tri­al that test­ed En­tyvio as a main­te­nance ther­a­py giv­en sub­cu­ta­neous­ly.

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