CHMP opinions for October

CHMP has recommended approval of five new therapies and indication expansions for 10.

Among the recommendations are orphan drug pegcetacoplan, which was considered by CHMP under the name Aspaveli but approved by FDA in 2021 as Empaveli. SFJ Pharmaceuticals Inc., which is backed by Blackstone and Abingworth and partnered with Apellis Pharmaceuticals Inc. (NASDAQ:APLS) to develop pegcetacoplan in the U.S., will be eligible for further payments if the CHMP recommendation becomes a formal approval. ...