Danicopan

FDA Drug Profile — Voydeya

Drug Details

Generic Name
Danicopan
Brand Names
Voydeya
Application Number
NDA218037
Sponsor
Alexion Pharmaceuticals Inc.
NDC Codes
3
Dosage Forms
KIT, TABLET, FILM COATED
Routes
ORAL
Active Ingredients
DANICOPAN

Indications and Usage

1 INDICATIONS AND USAGE VOYDEYA is indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH). VOYDEYA is a complement factor D inhibitor indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH) ( 1 ). Limitations of Use VOYDEYA has not been shown to be effective as monotherapy and should only be prescribed as an add-on to ravulizumab or eculizumab. Limitations of Use VOYDEYA has not been shown to be effective as monotherapy and should only be prescribed as an add-on to ravulizumab or eculizumab.