EMA recommends arpraziquantel to treat schistosomiasis in children

The European Medicines Agency (EMA) has adopted a positive scientific opinion for arpraziquantel for the treatment of schistosomiasis in preschool children (3 months to 6 years old), the Brazilian research organization Fiocruz has announced.

The application was submitted by the Pediatric Praziquantel Consortium, under the EU-M4all procedure for high-priority medicines for human use intended for countries outside the European Union. In Brazil, the regulatory submission to the Brazilian Health Regulatory Agency (Anvisa) will be carried out by the Consortium's partner, the Institute of Drug Technology (Farmanguinhos/Fiocruz).

The positive scientific opinion issued by the EMA is the basis for the possible inclusion of arpraziquantel on the World Health Organization's (WHO) list of essential and pre-qualified medicines. Farmanguinhos brings its experience in production and distribution and will be the manufacturing site, after Brazil’s regulator Anvisa's approval, for the future introduction of the new pediatric medicine in endemic countries.