Apellis seeks reexamination after negative opinion for pegcetacoplan in Europe
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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.”
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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 expects a final opinion in the fourth quarter.
“We remain steadfast in our commitment to GA patients in Europe who have no treatment for this devastating disease, which leads to irreversible vision loss,” Jeffrey Eisele, PhD, chief development officer of Apellis, said in the release. “It is encouraging to see the broad support for pegcetacoplan within the European retina community, and we are focused on promptly initiating the reexamination to bring this important treatment to those in need.”
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