FDA sets spring decision date for Madrigal’s NASH treatment, days after company announced new CEO

Madri­gal Phar­ma­ceu­ti­cals an­nounced Wednes­day that the FDA has set a March dead­line for its de­ci­sion on Madri­gal’s treat­ment for a liv­er dis­ease called non­al­co­holic steato­hep­ati­tis, or NASH. If ap­proved, resme­tirom would be­come the first com­mer­cial­ly avail­able treat­ment specif­i­cal­ly for NASH.

The FDA’s dead­line is March 14, and the reg­u­la­tor does not plan to hold an ad­vi­so­ry com­mit­tee meet­ing, ac­cord­ing to Madri­gal’s re­lease. The com­pa­ny is seek­ing ac­cel­er­at­ed ap­proval of resme­tirom based on one-year re­sults from a Phase III study that sug­gest­ed more pa­tients who re­ceived the treat­ment saw NASH res­o­lu­tion and im­proved liv­er scar­ring com­pared to those who got place­bo.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.