EMA’s CHMP recommends new indications for Dupixent, Skyrizi
May decisions also include CStone’s PD-1 inhibitor and Pfizer’s Factor IX gene therapy
EMA’s CHMP recommended approval of seven new medicines and label expansions for six, including new indications for Dupixent and Skyrizi.
In May’s review meeting, the committee issued a positive opinion on approval of Dupixent dupilumab from Sanofi (Euronext:SAN; NASDAQ:SNY) as an add-on therapy for chronic obstructive pulmonary disease, a large indication that would help scale Dupixent’s sales, a priority of Sanofi CEO Paul Hudson. ...