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Primo paese in Africa registra Eurartesim® (dihydroartemisinin-piperaquine) Ghana approva il nuovo anti-malarico sviluppato insieme a MMV


News provided by

Sigma-Tau

Mar 07, 2013, 01:00 ET

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GENEVA, March 7, 2013 /PRNewswire/ --

Il Ghana è il primo paese ad approvare Eurartesim®, una terapia combinata in dose fissa composta da diidroartemisinina e piperachina, a base di artemisinina (ACT) consigliata nelle linee guida del OMS per il trattamento della  malaria non complicata da P. falciparum. Eurartesim® è stata  approvata dalla European Medicines Agency (EMA) nel 2011 in seguito allo sviluppo in collaborazione tra Sigma-Tau e MMV.

Si tratta di una pietra miliare fondamentale per il trattamento della malaria in Africa. Molti paesi africani hanno utilizzato versioni di DHA-PQP in passato senza alcun garanzia di qualità, mentre altri hanno voluto inserire la medicina nei loro programmi di sovvenzioni internazionali. Questa registrazione punto di riferimento in Ghana, una qualità garantita versione di DHA-PQP sarà ora alla portata di pazienti africani.

Inoltre, questa registrazione consentirà l'uso dell'Eurartesim all'interno del programma INESS Fase IV che raccoglie dati sulla sicurezza ed efficacia di nuove ACT e condivide le informazioni con altri paesi endemici per la malaria. MMV e Sigma-Tau stanno lavorando insieme per registrare il farmaco per l'utilizzo in altri paesi endemici, tra cui tutti i paesi inclusi nel programma INESS (Ghana, Burkina Faso, Mozambique and Tanzania).

Ghana ha già adottato DHA-PQP per il trattamento della malaria insieme ad altri trattamenti di prima linea. Completata la registrazione di Eurartesim® adesso lo stato può procurare il farmaco attraverso le agenzie di aiuti internazionali e portare alle popolazioni maggiori medicinali di alta qualità.

Una più ampia gamma di terapie per trattare la malaria consente ai paesi endemici di adeguare le strategie di controllo per le loro esigenze specifiche. L'uso di più terapie di prima linea contro la malaria produce potenzialmente un risultato clinico migliore che usare una singola terapia, in particolare quando ci sono casi di resistenza ai farmaci o fallimenti terapeutici.

"Siamo molto soddisfatti con la notizia della registrazione di Eurartesim e attendiamo ulteriori registrazioni in futuro in modo che il farmaco possa essere utilizzato in tutti i paesi INESS, appena possibile," ha detto il Prof. Fred Binka, Capo ricercatore della squadra INESS. "I dati generati da INESS ci daranno informazioni uniche sulla sicurezza / efficacia di Eurartesim e ci mostreranno come può meglio essere utilizzato il farmaco nel trattamento della malaria."

Per maggiori informazioni:
Sigma-Tau's sito web: http://www.sigma-tau.it
Sigma-Tau
Bruno Chiavazzo, Head of Communication and Information
E-mail:[email protected]
Phone +39-06-91393963

MMV's sito web: http://www.mmv.org
MMV
Jaya Banerji, Director Communications & Advocacy
E-mail:[email protected]
Phone +41-79-707-7181

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