An­oth­er day, an­oth­er de­lay: FDA push­es back a sec­ond re­view for Ab­b­Vie's Rin­voq, this time in atopic der­mati­tis

Ab­b­Vie is con­tin­u­ing to look for ways to ex­pand its Rin­voq fran­chise, bet­ting the drug can be the next big thing once Hu­mi­ra’s patent runs out in a cou­ple years. But on Fri­day the phar­ma ran in­to its sec­ond stum­bling block at the FDA in the last few weeks.

Reg­u­la­tors have ex­tend­ed the re­view pe­ri­od for Rin­voq, al­so known as upadac­i­tinib, in mod­er­ate to se­vere atopic der­mati­tis by three months un­til ear­ly in the third quar­ter, Ab­b­Vie an­nounced Fri­day, cit­ing the agency’s re­quest for an up­dat­ed ben­e­fit-risk pro­file. The de­lay fol­lows a sep­a­rate ex­ten­sion for the drug in pso­ri­at­ic arthri­tis in mid-March.

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