Apellis announces validation for four marketing applications for pegcetacoplan

Apellis Pharmaceuticals announced that the company has received validation of its marketing applications by regulatory authorities in Canada, Australia, the United Kingdom, and Switzerland for intravitreal pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration. Decisions by local regulatory authorities in these countries are expected in the first half of 2024. "With our first approval of pegcetacoplan in the U.S. and multiple global decisions to be expected within the next year, we are closer than ever to achieving our goal of bringing pegcetacoplan to patients worldwide," said Jeffrey Eisele, Ph.D., chief development officer at Apellis. "We look forward to working with regulators in Canada, Australia, the United Kingdom, and Switzerland to deliver the first potential treatment for GA in these countries." A marketing authorization application for pegcetacoplan is under review by the European Medicines Agency with a decision expected in early 2024.