Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthri­tis Ad­vi­so­ry Com­mit­tee on Thurs­day vot­ed 10 for and 8 against the ap­proval of Chemo­Cen­tryx’s $CCXI in­ves­ti­ga­tion­al drug ava­co­pan as a treat­ment for adults with a rare and se­ri­ous dis­ease known as an­ti-neu­trophil cy­to­plas­mic au­toan­ti­body (AN­CA)-vas­culi­tis.

The vote on whether the FDA should ap­prove the drug was pre­ced­ed by a split vote of 9 to 9 on whether the ef­fi­ca­cy da­ta sup­port ap­proval, and 10 to 8 that the safe­ty pro­file of ava­co­pan is ad­e­quate enough to sup­port ap­proval.

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