Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA)

Inclusion Criteria:

• Diagnosis of PNH

• Clinically Evident EVH defined by:

• Anemia (Hgb ≤9.5 gram/deciliter) with absolute reticulocyte count ≥120 x 10^9/liter

• Receiving an approved C5 inhibitor for at least 6 months prior to Day 1

• Platelet count ≥30,000/microliters (µL)

• Absolute neutrophil counts ≥500/μL

• Documentation of/or willingness to receive vaccinations for N. meningiditis andprophylactic antibiotics as required

Exclusion Criteria:

• History of a major organ transplant or hematopoietic stem cell transplantation (HSCT)

• Participants with known aplastic anemia or other bone marrow failure that requiresHSCT or other therapies including anti-thymocyte globulin and/or immunosuppressants

• Known or suspected complement deficiency

• Laboratory abnormalities at screening, including:

• Alanine aminotransferase >2 x ULN (>3 x ULN in case of patients with documentedliver iron overload defined by serum ferratin values

• 500 ng/ML)

• Direct bilirubin >2 x ULN (unless due to EVH or documented Gilbert's Syndrome)

• Current evidence of biliary cholestasis

• Estimated glomerular filtration rate of <30 milliliters/minute/1.73 meter squaredand/or are on dialysis

• Evidence of human immunodeficiency virus, hepatitis B, or active hepatitis Cinfection at screening