FDA ap­proves Re­gen­eron's an­ti­body for rare im­mune dis­ease, re­solves man­u­fac­tur­ing is­sues for afliber­cept

The FDA ap­proved Re­gen­eron’s poze­limab, the first treat­ment for a rare, hered­i­tary im­mune dis­ease that af­fects few­er than 100 peo­ple world­wide.

The mon­o­clon­al an­ti­body, to be mar­ket­ed as Veopoz, is ex­pect­ed to be made avail­able to pa­tients this quar­ter, a Re­gen­eron spokesper­son told End­points News. It’s cleared to treat adults and chil­dren 1 year and old­er with Chap­le dis­ease, a po­ten­tial­ly life-threat­en­ing con­di­tion that of­ten man­i­fests in chil­dren and can cause se­vere gas­troin­testi­nal is­sues or blood clots.

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