CDER drafts drug de­vel­op­ment guid­ance on NASH with com­pen­sat­ed cir­rho­sis

The Cen­ter for Drug Eval­u­a­tion and Re­search (CDER) at the FDA is­sued draft rec­om­men­da­tions for spon­sors look­ing to de­vel­op drugs to treat non­al­co­holic steato­hep­ati­tis (NASH) with com­pen­sat­ed cir­rho­sis.

NASH is as­so­ci­at­ed with a range of com­mon dis­eases, in­clud­ing type 2 di­a­betes, hy­per­ten­sion and obe­si­ty, among oth­ers. “It is a grow­ing pub­lic health con­cern and is an­tic­i­pat­ed to be the lead­ing cause of liv­er trans­plan­ta­tion with­in a decade,” the agency says. But “no stan­dard treat­ment ex­ists for NASH.”

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