EMA’s CHMP backs approval of Novartis’ complement drug

Among the four new medicines EMA’s CHMP recommended in its March review meeting was Novartis’ Fabhalta, a treatment for paroxymal nocturnal hemoglobinuria that pharma views as a pipeline-in-a-product opportunity.

Fabhalta iptacopan is a complement factor B inhibitor (CFB) that could help quell inflammation in a variety of disease contexts. FDA approved the therapy for paroxymal nocturnal hemoglobinuria in December, marking both the drug’s first authorization and the disease’s first oral therapy...