FDA OKs danicopan as add-on therapy for extravascular hemolysis in PNH

Danicopan (Voydeya) is a complement factor D inhibitor indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria. Approval was based on data from the phase 3 ALPHA trial. The Voydeya label includes a Boxed Warning pertaining to an increased risk for serious and life-threatening infections caused by encapsulated bacteria, including N. meningitidis, S. pneumoniae, and H. influenzae type B. The drug will be available only through a restricted program (Voydeya REMS).