FDA rejects higher dose of Regeneron blockbuster due to contractor issues

Re­gen­eron said late Tues­day that the FDA re­ject­ed its new, 8-mg ver­sion of its block­buster Eylea (afliber­cept) due to an on­go­ing re­view of in­spec­tion find­ings at a third-par­ty filler. Re­gen­eron stock shares fell by al­most 8% af­ter the an­nounce­ment.

The com­plete re­sponse let­ter is a ma­jor blow to the New York-based com­pa­ny’s at­tempt to ex­pand the use of its eye in­jec­tion for the treat­ment of pa­tients with wet age-re­lat­ed mac­u­lar de­gen­er­a­tion, di­a­bet­ic mac­u­lar ede­ma and di­a­bet­ic retinopa­thy. The com­pa­ny al­so had sought to speed the FDA’s re­view of this ap­pli­ca­tion with a pri­or­i­ty re­view vouch­er, which typ­i­cal­ly cost about $100 mil­lion.

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