Merck Healthcare, a leading science and technology company, and the Pediatric Praziquantel Consortium today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive scientific opinion for arpraziquantel for the treatment of schistosomiasis in children aged 3 months to 6 years.
The application was submitted by Merck, on behalf of the Consortium, under the EU-M4all procedure for high-priority medicines for human use intended for countries outside the European Union.
“With this positive response by EMA, a critical milestone was achieved to broaden the range of options for the treatment of schistosomiasis so as to address the needs of millions of preschool-aged children”, said Peter Guenter, Member of the Executive Board and CEO of Healthcare at Merck. “I thank all partners of the Pediatric Praziquantel Consortium for this achievement and for the continuous collaboration. Together, we strive to contribute to the elimination of schistosomiasis as a public health problem by 2030, as part of our commitment to drive health equity through our innovations and products.”
Arpraziquantel is derived from praziquantel, the standard of care treatment of schistosomiasis developed in the 1970s. Extending the range of options for the treatment of schistosomiasis, arpraziquantel is tailored for use in preschool-aged children. The tablet is administered by dissolving it in water and has an improved taste to make it more palatable for very young children. In addition, the 150mg tablet has been specifically designed to withstand the hot and humid conditions presented by a tropical climate.
The positive CHMP scientific opinion by EMA is the basis for a potential inclusion of arpraziquantel in 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.
👉 Arpraziquantel EMA Response | Merck (merckgroup.com)
