FDA approves Madrigal’s NASH drug, marking the first-ever treatment for the liver disease

Madri­gal Phar­ma­ceu­ti­cals’ NASH drug won an ac­cel­er­at­ed ap­proval on Thurs­day, be­com­ing the first treat­ment for a liv­er dis­ease that for years has vexed sci­en­tists and in­vestors.

The med­ica­tion, resme­tirom, was ap­proved un­der the brand name Rezd­if­fra for pa­tients with stage 2 and 3 fi­bro­sis. It’s ex­pect­ed to be avail­able in April, ac­cord­ing to Madri­gal. While the FDA de­scribed the dis­ease as NASH in its la­bel, it is now of­ten re­ferred to as meta­bol­ic dys­func­tion-as­so­ci­at­ed steato­hep­ati­tis (MASH).

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