The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a negative opinion on the marketing authorization application for pegcetacoplan for the treatment of geographic atrophy.
According to a press release, Apellis Pharmaceuticals is seeking reexamination, noting “there were multiple dissenting votes by CHMP members to this opinion.”
An ad hoc expert group previously determined that geographic atrophy (GA) lesion size is an acceptable primary outcome measure for a trial and that microperimetry is the best available functional measure of GA.
Apellis