At its January meeting, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending revisions to the approved indications for Noxafil (posaconazole, Merck). 

The changes expand and clarify how the drug may be used in pediatric patients from 2 years of age and remove the requirement for prior treatment failure in cases of invasive aspergillosis across several formulations.

The recommendation represents a modification to the current marketing authorization and will require adoption by the European Commission before taking effect.

Updates to Indications 

A central change in the updated indications is that treatment of invasive aspergillosis is no longer limited to patients with refractory disease or intolerance to prior antifungal therapy. This applies consistently across the following formulations:

• Gastro-resistant tablets in adults and pediatric patients from 2 years of age weighing more than 40 kg
• Concentrate for solution for infusion in adults and pediatric patients from 2 years of age
• Gastro-resistant powder and solvent for oral suspension in pediatric patients from 2 years of age

This represents a meaningful expansion of clinical use, allowing Noxafil to be used for invasive aspergillosis irrespective of prior treatment response, within the age and formulation-specific criteria defined in the Summary of Product Characteristics.

For other invasive fungal infections, the updated indications continue to limit use of Noxafil to patients whose disease is refractory to standard antifungal therapy or who are intolerant of it, regardless of formulation. These infections include:

• Fusariosis
• Chromoblastomycosis and mycetoma
• Coccidioidomycosis

Refractory disease is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal treatment.

Prophylaxis in High-Risk Patients

Across the relevant formulations, Noxafil remains indicated for prophylaxis of invasive fungal infections in patients at high risk. This includes individuals receiving remission-induction chemotherapy for acute myelogenous leukaemia or myelodysplastic syndromes with expected prolonged neutropenia, as well as haematopoietic stem cell transplant recipients undergoing high-dose immunosuppressive therapy for graft-versus-host disease.

Regulatory Next Steps 

Detailed prescribing guidance will be provided in the updated Summary of Product Characteristics, which will be published on the EMA website in all official European Union languages following the European Commission’s formal decision on the marketing authorization change.