The European Medicines Agency adopts positive opinion of our treatment option for schistosomiasis in preschool-aged children

The announcement was made following formal notification by EMA’s Committee for Medicinal Products for Human Use (CHMP). EMA assessed our new treatment option under the EU-M4all procedure for high-priority medicines intended for use in countries outside the European Union. 

Commenting on the news, Dr. Jutta Reinhard-Rupp, Chair of the Pediatric Praziquantel Consortium Board and Head of the Global Health Institute at Merck said: “After more than 10 years of intense collaboration, we are thrilled to have received a positive scientific opinion from EMA. I am extremely proud of our Consortium of dedicated partners. Together, we have come a long way in our vision of providing a treatment option for the most vulnerable population – the youngest. This will contribute to reducing the global disease burden of schistosomiasis, a neglected tropical disease that affects approximately 240 million people worldwide. Now, we all need to turn our full attention to access and delivery.”   

The Consortium's work to develop, register, and provide access to the new treatment option is a tangible contribution to the elimination of schistosomiasis as a public health problem. 

Congratulating the Consortium on this latest achievement, our funding partners, EDCTP and the GHIT Fund, shared the following words: 

“We are delighted that our 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 preschoolers in affected countries through the ADOPT project,” said Dr Michelle Helinski, Senior Project Officer responsible for neglected infectious diseases at EDCTP. 

“We are very excited and highly encouraged by the news of the EMA's positive scientific opinion of the potential new treatment for schistosomiasis in preschool-aged children, and proud to have been part of this journey since our establishment. This momentous achievement is due to a longstanding and dedicated partnership and reflects the collaborative efforts of all involved in its development. We believe the new treatment option brings a bright future outlook for the very young children and their communities and the success of this developmental milestone is inspiring to the global health community. There is still some more work to be done to determine the optimal models of care and to ensure that the treatment reaches quickly and is affordable. GHIT continues to support those efforts as well,” said Dr Osamu Kunii, CEO of the GHIT Fund. 

Read the full press release¹

Find out more on the EMA website

The press release is also available in Japanese, Brazilian Portuguese, and French. 

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¹US version available here