FDA ap­proves high dose of Re­gen­eron's eye treat­ment Eylea in quick bounce­back from June re­jec­tion

The FDA OK’d a high-dose ver­sion of Re­gen­eron’s eye dis­ease in­jectable Eylea on Fri­day evening just two months af­ter de­fi­cien­cies at the bio­phar­ma’s third-par­ty man­u­fac­tur­er up­end­ed a speedy re­view that had re­sult­ed in re­jec­tion on June 27.

The green light comes the same day as Re­gen­eron se­cured the first-ever drug ap­proval for an ul­tra-rare im­mune dis­ease. Both treat­ments were part of the same pre-ap­proval in­spec­tion at a Catal­ent man­u­fac­tur­ing fa­cil­i­ty in In­di­ana. Ear­li­er Fri­day af­ter­noon, Re­gen­eron had said it ex­pect­ed an Eylea de­ci­sion in the com­ing weeks.

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