The CHMP initially adopted a negative opinion in January after finding it was unable to establish a positive balance of benefits and risks for Syfovre, but Apellis sought a re-examination and was able to submit new data in support of its application following an unrelated court ruling in Europe.

This CHMP opinion was made despite broad support for pegcetacoplan from the European retina community and multiple dissenting votes by CHMP members who supported a path to approval.” “We have seen the profound impact this medicine has had for GA patients in the U.