Schistosoma mansoni

EMA Recommends Arpraziquantel for Treatment of Schistosomiasis in Preschool-Aged Children

Retrieved on: 
Monday, December 18, 2023

TOKYO, Dec. 18, 2023 /PRNewswire/ -- The Global Health Innovative Technology (GHIT) Fund has supported the Pediatric Praziquantel Consortium's development of arpraziquantel since 2013 through a total investment of approximately 1.85 billion Japanese yen. On December 15, the Consortium announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion for arpraziquantel to treat schistosomiasis in preschool-aged children. Arpraziquantel is the first investigational drug to receive positive scientific opinion amongst the projects funded by the GHIT Fund. Present in 78 countries and endemic in 51, schistosomiasis affects more than 240 million people, about 50 million of whom are preschool-aged children. Leveraging Japanese innovation and leadership in the global fight against neglected tropical diseases (NTDs), GHIT Fund invests in global health R&D and facilitates transformational cross-border public-private partnerships.

Key Points: 
  • On December 15, the Consortium announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion for arpraziquantel to treat schistosomiasis in preschool-aged children.
  • Present in 78 countries and endemic in 51, schistosomiasis affects more than 240 million people, about 50 million of whom are preschool-aged children.
  • Extending the range of options for the treatment of schistosomiasis, arpraziquantel is tailored for preschool-aged children against Schistosoma mansoni and Schistosoma haematobium.
  • Its mission is to develop, register, and provide access to a suitable pediatric drug for treating schistosomiasis in children 3 months to 6 years of age.

The European Medicines Agency (EMA) Validated Regulatory Application for Arpraziquantel, a Potential Treatment for Schistosomiasis in Preschool-Aged Children

Retrieved on: 
Monday, January 23, 2023

Arpraziquantel, developed by the Pediatric Praziquantel Consortium, is a potential new treatment option tailored to improve child health by filling the treatment gap of an estimated 50 million preschool-aged children with schistosomiasis.

Key Points: 
  • Arpraziquantel, developed by the Pediatric Praziquantel Consortium, is a potential new treatment option tailored to improve child health by filling the treatment gap of an estimated 50 million preschool-aged children with schistosomiasis.
  • On behalf of the Pediatric Praziquantel Consortium, Merck submitted the regulatory application for arpraziquantel to the European Medicines Agency (EMA), which validated this application and started the scientific review process in December 2022.
  • Arpraziquantel represents the first investigational drug that has reached the regulatory phase amongst the portfolio of projects supported by GHIT Fund.
  • The drug praziquantel – the current standard treatment developed in the 1970s – is safe, effective and available for school-aged children and adults.