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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.