Madrigal seeks accelerated approval for experimental NASH treatment a week after Intercept rejection

Madri­gal Phar­ma­ceu­ti­cals kicked off the reg­u­la­to­ry re­view process for its ex­per­i­men­tal NASH treat­ment as it pur­sues the first FDA ap­proval to treat the de­bil­i­tat­ing and some­times fa­tal liv­er dis­ease for which no oth­er ther­a­pies ex­ist.

Madri­gal an­nounced Fri­day that it be­gan a rolling sub­mis­sion for ac­cel­er­at­ed ap­proval of resme­tirom as a treat­ment for NASH with liv­er fi­bro­sis, based on da­ta show­ing that the thy­roid hor­mone be­ta-re­cep­tor ag­o­nist met both pri­ma­ry sur­ro­gate end­points in a Phase III tri­al. The com­pa­ny said it sub­mit­ted the ma­jor­i­ty of its NDA, and it plans to file the re­main­ing com­po­nents in Ju­ly.

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