ECALTA (anidulafungine) - Candidoses pédiatriques

Key points

Favourable opinion for reimbursement only in the treatment of invasive candidiasis in non-neutropenic patients aged 1 month to < 18 years.

Unfavourable opinion for reimbursement in the treatment of invasive candidiasis in neutropenic patients aged 1 month to < 18 years.

What therapeutic improvement?

As in adults, no clinical added value in the therapeutic strategy.

Role in the care pathway?

Invasive candidiasis is a relatively common syndrome in neonates and children. It is associated with a high level of morbidity and mortality. Invasive candidiasis in children from the age of 1 month is similar to that adults. It is a significant cause of nosocomial infection in patients treated with in-dwelling central catheters, children with malignant blood diseases and in patients receiving haematopoietic stem cell transplants or in the context of solid organ transplantation.

Treatment is currently based on the three antifungal families available for the treatment of invasive candidiasis:

- polyenes: liposomal amphotericin B (AMBISOME), which has an MA in children in the event of renal impairment developed under treatment with amphotericin B or pre-existing and persistent renal function impairment;

- echinocandins: caspofungin (CANCIDAS), which has an MA from 12 months, and micafungin (MYCAMINE), which has an MA in children, including neonates, only if administration of other antifungals is not appropriate;

- azole substances: fluconazole (TRIFLUCAN), which has an MA in term newborn infants, infants, toddlers, children and adolescents aged from 0 to 17 years old, and voriconazole (VFEND), which has an MA in children aged 2 years and above.

The choice of antifungal depends on several factors: the efficacy of the substances, the ecology, the severity of the clinical profile, the underlying health status (renal and hepatic function, etc.), the associated infection sites (CNS, eye, bones, etc.), previous or ongoing antifungal prophylaxis.

Role of the medicinal product in the care pathway

In non-neutropenic patients aged 1 month to < 18 years, fluconazole remains the reference treatment in the majority of cases. ECALTA (anidulafungin) is an additional therapeutic resource in view of the other treatments available in non-neutropenic paediatric patients from 1 month of age with invasive candidiasis.

As in neutropenic adults, in neutropenic patients aged 1 month to < 18 years, ECALTA (anidulafungin) has no role in the care pathway due to the low level of evidence of efficacy compared to the available alternatives.