Chemo­Cen­tryx gets new PDU­FA date af­ter ma­jor amend­ment; Nim­i­um launch­es with eye on obe­si­ty

Fol­low­ing talks with the FDA, Chemo­Cen­tryx on Mon­day filed an amend­ment to its ap­pli­ca­tion for ava­co­pan as a treat­ment of an­ti-neu­trophil cy­to­plas­mic au­toan­ti­body (AN­CA)-as­so­ci­at­ed vas­culi­tis, re­sult­ing in a new PDU­FA goal date of Oct. 7.

While the com­pa­ny did not ex­plain what was con­tained in the amend­ment fil­ing, its stock spiked by more than 10% on the news. How the agency will ul­ti­mate­ly de­cide on the drug re­mains a mys­tery. The agency’s Arthri­tis Ad­vi­so­ry Com­mit­tee in May vot­ed 9-9 on whether the ef­fi­ca­cy da­ta from a small Phase III tri­al sup­port ap­proval of ava­co­pan, 10-8 in fa­vor of the drug’s safe­ty pro­file, and 10-8 that the ben­e­fit-risk pro­file is ad­e­quate to sup­port ap­proval.

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