Apellis announces FDA acceptance of NDA amendment and new PDUFA date of 26 February 2023 for pegcetacoplan for geographic atrophy

Apellis Pharmaceuticals

18 November 2022 - Apellis Pharmaceuticals today announced that the US FDA has accepted Apellis’ unsolicited major amendment to the new drug application for intravitreal pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration. 

The updated Prescription Drug User Fee Act goal date is 26 February 2023.

Read Apellis Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Medicine , US , Timelines , Dossier