Still bathing in the af­ter­glow of its big-mon­ey ac­qui­si­tion of Al­ler­gan, Ab­b­Vie faces the dark cloud of a post-Hu­mi­ra fu­ture — and the dead­line is ap­proach­ing fast. Key to Ab­b­Vie’s plan are two im­munol­o­gy launch­es with ag­gres­sive clin­i­cal dreams; one of those, JAK in­hibitor Rin­voq, is now one step clos­er to an­oth­er Hu­mi­ra-match­ing ap­proval.

Ab­b­Vie’s Rin­voq (upadac­i­tinib) best­ed place­bo in help­ing ul­cer­a­tive col­i­tis pa­tients achieve clin­i­cal re­mis­sion at the eight-week mark and sig­nif­i­cant­ly re­duced key symp­to­matic bio­mark­ers, in­clud­ing gas­troin­testi­nal in­flam­ma­tion, ac­cord­ing to da­ta from the Phase III U-Achieve study un­veiled Wednes­day.

Twen­ty-six per­cent of pa­tients dosed with a once-dai­ly, 45-mg dose of Rin­voq hit clin­i­cal re­mis­sion af­ter two months com­pared with just 5% on place­bo, Ab­b­Vie said. Rin­voq al­so in­duced gas­troin­testi­nal im­prove­ment in 36% of pa­tients; mean­while, just 7% pa­tients on place­bo hit that mark.

Rin­voq al­so aced its oth­er sec­ondary end­points over place­bo, in­clud­ing achiev­ing clin­i­cal re­sponse in pa­tients and re­duc­ing swelling of the mu­cos­al lin­ing. U-Achieve is one of two in­duc­tive stud­ies Ab­b­Vie has planned for Rin­voq in UC along with three piv­otal tri­als for a pos­si­ble reg­u­la­to­ry sub­mis­sion.

Rin­voq’s UC quest is part of a wide-rang­ing clin­i­cal pro­gram for the drug that in­cludes on­go­ing late-stage tri­als for un­ap­proved in­di­ca­tions in atopic der­mati­tis, pso­ri­at­ic arthri­tis, ax­i­al spondy­loarthri­tis, Crohn’s dis­ease, gi­ant cell ar­teri­tis and Takaya­su’s ar­teri­tis.

The end goal is sim­ple and dri­ven by a loom­ing axe in Ab­b­Vie’s port­fo­lio: Rin­voq must even­tu­al­ly snare enough in­di­ca­tions to make up for the sales loss of megablock­buster Hu­mi­ra, which is fac­ing US biosim­i­lar com­pe­ti­tion start­ing in 2023.

That time­line would give Rin­voq, which orig­i­nal­ly notched an FDA ap­proval to treat mod­er­ate-to-se­vere rheuma­toid arthri­tis back in Au­gust 2019, rough­ly three years to gain enough mo­men­tum to be­gin off­set­ting Hu­mi­ra’s ex­pect­ed de­cline. But it won’t be a sure-fire path to suc­cess: Rin­voq sports a JAK class warn­ing la­bel for se­ri­ous in­fec­tions, ma­lig­nan­cy and throm­bo­sis that has spooked many rheuma­tol­o­gists off the drugs and could make a ma­jor mar­ket en­try in­to any of those new in­di­ca­tions a dif­fi­cult road.

Luck­i­ly, Ab­b­Vie isn’t putting all its eggs in­to one bas­ket as it looks in­to the post-Hu­mi­ra fu­ture. The Chica­go drug­mak­er al­so sports re­cent pso­ri­a­sis launch Skyrizi, which it hopes to pair up with Rin­voq as a one-two punch to match Hu­mi­ra high­est sales peak. Ab­b­Vie is so gung-ho about the pair’s chances that CEO Rick Gon­za­lez posit­ed in Jan­u­ary at the JP Mor­gan Health­care Con­fer­ence that the two drugs could hit a com­bined $20 bil­lion in an­nu­al sales if they snag all of Hu­mi­ra’s ap­provals and add more — atopic der­mati­tis, for in­stance.

Mean­while, Ab­b­Vie is still in the process of di­gest­ing its $63 bil­lion ac­qui­si­tion of Al­ler­gan, which brought aes­thet­ic/ther­a­peu­tic block­buster Botox in­to the fold. Al­ler­gan came in sport­ing boom­ing an­tipsy­chot­ic Vray­lar as well, tack­ing a sec­ond growth dri­ver on­to the new com­pa­ny’s lapel.

As more and more biopharmas develop artificial intelligence platforms, the drug discovery process is being reshaped to fit new goals on cutting down the prodigious amount of time, energy and money that go into a drug program. Now one of the most ambitious players in the drive to improve on ROI, AstraZeneca, is marking a milestone on that front by adding the first target generated by AI to its portfolio.