Posaconazole

Active substance Posaconazole
Domain Infectious diseases
Reason of inclusion in Horizonscan Geneesmiddelen Generic
Main indication Other infectious diseases
Extended indication Posaconazole Accord is indicated for use in the treatment of the following fungal infections in adults: - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Posaconazole Accord is also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.

Product

Current proprietary name Noxafil (MSD)
Proprietary name Posaconazole Accord
Manufacturer Accord Healthcare
Mechanism of action Antifungals
Additional comments Dit betreft 1 van de twee generieken voor posaconazole die is opgenomen in de Horizonscan.

Registration

Registration route Centralised (EMA)
Submission date June 2018
Expected Registration July 2019
Orphan drug No
Registration phase Registered
Additional comments SPC Noxafil verloopt op 19 december 2019. Positieve CHMP-opinie mei 2019. Geregistreerd in juli 2019.

Therapeutic value

Therapeutic value Potential equal value
Duration of treatment Not found

Expected patient volume per year

Patiëntvolume is niet van toepassing bij generieke geneesmiddelen of biosimilars.

Expected cost per patient per year

Horizonscan vermeldt geen prijsinformatie van generieke geneesmiddelen of biosimilars om het eventueel beïnvloeden van de markt te voorkomen.

Potential total cost per year

Horizonscan vermeldt geen prijsinformatie van generieke geneesmiddelen of biosimilars om het eventueel beïnvloeden van de markt te voorkomen.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.