EMA recommends arpraziquantel for treatment of schistosomiasis in preschool-aged children
Today, the Pediatric Praziquantel Consortium announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive scientific opinion for arpraziquantel to treat schistosomiasis in preschool-aged children (3 months to 6 years of age).
“We are delighted that EDCTP funding contributed to this group effort to move this treatment from the development into the launch stage. We look forward to our continued engagement with the Pediatric Praziquantel Consortium to make the product available to pre-schoolers in affected countries through the ADOPT project.”
Dr Michelle Helinski, EDCTP Senior Project Officer responsible for neglected infectious diseases
The positive scientific opinion considered all supporting evidence, including the results of the pivotal phase III trial in Côte d’Ivoire and Kenya – which showed excellent efficacy of arpraziquantel, achieving cure rates of 90% or above, and was safe and well tolerated by young children affected by schistosomiasis. This trial was co-funded by EDCTP and the Global Health Innovative Technology (GHIT) through the PZQ4PSAC study.
The positive CHMP scientific opinion by EMA is the basis for the potential inclusion of arpraziquantel into the World Health Organization’s list of prequalified and essential medicinal products. Together with the positive scientific opinion, the planned prequalification will support the regulatory pathway in African countries.
In parallel with this regulatory work, the Consortium’s implementation research project, ADOPT, also co-funded by EDCTP and GHIT, is preparing for the introduction of arpraziquantel in the first endemic countries in Africa. To support equitable and sustainable access, it is essential that new procurement and funding mechanisms are collaboratively explored and established. The intent is to make the product available on a not-for-profit basis in sub-Saharan African countries.
More information
- Read the press release by the Pediatric Praziquantel Consortium
- Read the EMA’s news item
- Completion of Phase III trial paediatric schistosomiasis drug arpraziquantel (16 November 2021)
- GHIT and EDCTP co-invest additional €7.8 million in access programme for treatment of schistosomiasis in preschool-aged children(25 February 2021)