FDA ac­cepts Iver­ic Bio's NDA, grants pri­or­i­ty re­view for GA drug

On the heels of a sec­ond Phase III win in ge­o­graph­ic at­ro­phy last year, Iver­ic Bio is now wait­ing at the FDA’s doors for its fi­nal de­ci­sion, which is set to come af­ter com­peti­tor Apel­lis Phar­ma­ceu­ti­cals hears from the reg­u­la­tor lat­er this month.

The eye dis­ease-fo­cused biotech an­nounced Thurs­day af­ter­noon the FDA had ac­cept­ed Iver­ic’s NDA for avac­in­cap­tad pe­gol (ACP), a com­ple­ment C5 pro­tein in­hibitor and the biotech’s lead can­di­date. The biotech is seek­ing FDA ap­proval to treat ge­o­graph­ic at­ro­phy (GA) sec­ondary to age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD). Ge­o­graph­ic at­ro­phy is a se­vere form of dry AMD.

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