FDA is­sues draft guid­ance on NASH drug de­vel­op­ment

The FDA on Mon­day is­sued draft guid­ance on de­vel­op­ing drugs to treat pa­tients who have non­cir­rhot­ic non­al­co­holic steato­hep­ati­tis (NASH) with liv­er fi­bro­sis.

“Cur­rent­ly, there are no ap­proved drugs for the treat­ment of NASH. Giv­en the high preva­lence of NASH, the as­so­ci­at­ed mor­bid­i­ty, the grow­ing bur­den of end-stage liv­er dis­ease, and the lim­it­ed avail­abil­i­ty of liv­ers for or­gan trans­plan­ta­tion, FDA be­lieves that iden­ti­fy­ing ther­a­pies that will slow the progress or, halt, or re­verse NASH and NAFLD will ad­dress an un­met med­ical need,” FDA writes.

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