An Al­ler­gan psy­chi­atric drug failed late-stage de­pres­sion stud­ies — but Ab­b­Vie is go­ing for ap­proval any­way

Cariprazine, the Al­ler­gan-turned-Ab­b­Vie drug for bipo­lar de­pres­sion and schiz­o­phre­nia, had a rocky road through clin­i­cal tri­als be­fore its ap­provals. And as Ab­b­Vie at­tempts to fur­ther ex­pand in­to ma­jor de­pres­sive dis­or­der, it’s fac­ing sim­i­lar chal­lenges.

Ear­ly Fri­day morn­ing, Ab­b­Vie re­port­ed large­ly neg­a­tive da­ta in two Phase III stud­ies eval­u­at­ing cariprazine as an ad­junct in adults who re­spond­ed poor­ly to pre­vi­ous de­pres­sion treat­ment. De­spite the miss­es, the phar­ma in­tends to sub­mit for a sup­ple­men­tal NDA in MDD us­ing the “to­tal­i­ty” of da­ta, as one of these stud­ies showed a pos­i­tive sig­nal. An ear­li­er Phase II/III tri­al al­so proved pos­i­tive, Ab­b­Vie said.

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