Ab­b­Vie's stock and next megablock­buster take hits fol­low­ing new JAK warn­ings from FDA

While the FDA’s new warn­ings on JAK in­hibitors are based on a re­view of a Pfiz­er tri­al, it’s Ab­b­Vie that may be hurt the most.

Ab­b­Vie’s stock fell by about 10% at one point Wednes­day as its prized JAK in­hibitor Rin­voq, once fore­cast to haul in $8 bil­lion an­nu­al­ly by 2025, was looped in­to new class-wide FDA warn­ings, which in­clude risks of se­ri­ous heart-re­lat­ed events, can­cer, blood clots and death.

The re­view from the FDA fol­lows Pfiz­er’s an­nounce­ment in Jan­u­ary that its six-year post-mar­ket­ing tri­al for its JAK in­hibitor Xel­janz, known as ORAL Sur­veil­lance, had failed. Across 4,362 pa­tients, those who re­ceived ei­ther a low or high dose of Xel­janz ex­pe­ri­enced more ma­jor car­dio­vas­cu­lar events — such as stroke and heart at­tack — than those on com­para­tor TNF drugs Hu­mi­ra or En­brel. They al­so had high­er rates of can­cer with Pfiz­er fail­ing to hit non-in­fe­ri­or­i­ty on both pri­ma­ry end­points.

First ap­proved in 2019 for rheuma­toid arthri­tis, Rin­voq brought in $731 mil­lion in 2020 sales.

While Rin­voq has not been stud­ied in tri­als sim­i­lar to the large safe­ty clin­i­cal tri­al that the FDA re­viewed for Pfiz­er’s Xel­janz, the agency still said that be­cause they share the same mech­a­nisms of ac­tion the FDA con­sid­ers these drugs may have sim­i­lar risks as seen in the Xel­janz safe­ty tri­al. Wall Street an­a­lysts took is­sue with the ex­trap­o­la­tion, point­ing to what oth­er reg­u­la­tors have done.

Rin­voq is al­so still un­der FDA re­view in atopic der­mati­tis, pso­ri­at­ic arthri­tis and anky­los­ing spondyli­tis, and those de­ci­sions may be com­ing soon as the FDA post­poned all of its re­views of JAK sNDAs un­til this re­view of the Xel­janz tri­al fin­ished.

SVB Leerink an­a­lyst Ge­of­frey Porges wrote in a note to in­vestors Wednes­day:

In­ter­est­ing­ly, out­side the US, oth­er reg­u­la­tors have nei­ther im­posed these re­stric­tions, nor im­posed such oner­ous safe­ty lan­guage, nor have they treat­ed all the drugs in the class equal­ly with re­spect to safe­ty. In our dis­cus­sions with in­vestors the up­dat­ed safe­ty lan­guage seemed to be the most like­ly out­come, but we and most in­vestors had not an­tic­i­pat­ed the re­stric­tion to post-TNF pa­tients (even though that is how Rin­voq and oth­er JAKs are al­ready be­ing used in the US due to step-ed­it poli­cies and for­mu­la­ry re­stric­tions). The FDA’s state­ments do not of­fer any in­sight about whether the cur­rent re­views of the Rin­voq sNDAs for pso­ri­at­ic arthri­tis, anky­los­ing spondyli­tis, and atopic der­mati­tis will be af­fect­ed by this de­ci­sion, or whether Pfiz­er’s abroc­i­tinib can still be ap­proved in atopic der­mati­tis. We tend to be­lieve that the new in­di­ca­tions will be ap­proved, but with the caveats im­posed by to­day’s over­all reg­u­la­to­ry ac­tion but this is high­ly un­cer­tain.

Porges pre­vi­ous­ly es­ti­mat­ed that los­ing any one of these Rin­voq in­di­ca­tions could pose a $500 mil­lion to $1.5 bil­lion hit to the com­pa­ny’s long-term rev­enue ex­pec­ta­tions.

Ab­b­Vie did not re­spond to a re­quest for com­ment on the new FDA warn­ings.

Over­all, Porges said Rin­voq’s po­ten­tial “is al­most cer­tain­ly re­duced in the USA, by this la­bel­ing. How­ev­er, it still seems fea­si­ble that the prod­uct can get to the $3.5-4.5bn in US sales re­quired to sup­port the com­pa­ny’s long term guid­ance of $8bn in peak sales.”

The biggest is­sue with the FDA’s ac­tions to­day, Porges added, “is not the safe­ty dis­clo­sure, but in­stead the re­stric­tion to sec­ond-or lat­er-line treat­ment. Ab­b­Vie cer­tain­ly con­tem­plat­ed mov­ing Rin­voq in­to the first-line set­ting in RA, and al­so in new in­di­ca­tions such as PsA, AS, AD and even IBD. Those first-line in­di­ca­tions are now off the ta­ble, at least for the fore­see­able fu­ture.”

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