VIDEO: Specialist comments on pegcetacoplan rejection in Europe
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BARCELONA, Spain — In this Healio Video Perspective, Jean-François Korobelnik, MD, PhD, discusses the decision of the European Medicines Agency to reject marketing authorization of pegcetacoplan in Europe.
“As it was a second evaluation, the rejection is final. There will be no other appeal possible,” he told Healio at the Euretina congress.
The data for pegcetacoplan (Apellis Pharmaceuticals) for the treatment of geographic atrophy were positive, but not strongly positive, for the overall population of the trials, but post hoc analyses have shown high efficacy in specific subgroups of patients. However, the EMA does not accept post hoc data, Korobelnik said.
Korobelnik said he believes that approval of avacincaptad pegol intravitreal solution (Iveric Bio) is unlikely, and although other compounds are being studied, it will be many years before European patients with geographic atrophy will have an approved therapy.
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