NUCALA: The first and ONLY anti-IL-5 for
hypereosinophilic syndrome (HES)
NUCALA is indicated for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable nonhematologic secondary cause.
Primary Endpoint Results:
Proportion of patients who experienced HES flare(s)* during the 32-week study or withdrew: NUCALA 28% vs placebo 56%, P=0.002.
32-week study comparing NUCALA 300 mg subcutaneous every 4 weeks to placebo, each added to stable HES therapy, in 108 patients aged ≥12 years with HES. Patients experienced ≥2 HES flares in the past 12 months and had a blood eosinophil count of ≥1000 cells/μL at screening.
*HES flare: Worsening of clinical signs/symptoms or increased eosinophils (on ≥2 occasions), resulting in an escalation/addition of oral corticosteroids (OCS) or cytotoxic or immunosuppressive therapy.