FDA de­lays de­ci­sion for Apel­lis' eye dis­ease drug af­ter biotech sub­mits up­dat­ed da­ta

Apel­lis had se­cured a pri­or­i­ty re­view for its ge­o­graph­ic at­ro­phy pro­gram, but it turns out the FDA wants to wait a lit­tle bit longer be­fore mak­ing a de­ci­sion.

Reg­u­la­tors have pushed back their de­ci­sion date for pegc­eta­coplan from Nov. 26 to some­time next Feb­ru­ary, the biotech an­nounced Thurs­day af­ter­noon. The move comes af­ter Apel­lis said it would sub­mit two-year ef­fi­ca­cy da­ta from a pair of Phase III stud­ies, ad­di­tions the agency con­sid­ers a “ma­jor amend­ment.”

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