Merck KGaA, Darmstadt, Germany, 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 KGaA, Darmstadt, Germany, 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 KGaA, Darmstadt, Germany. “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.
In Brazil, regulatory submission is under preparation by Consortium partner, Farmanguinhos. As the federal governmental pharmaceutical laboratory of the Fiocruz Foundation in Brazil, Farmanguinhos brings expertise in production and distribution, and will be the manufacturing site for the future introduction of the new pediatric medication in endemic countries. For planned future large-scale local production to serve African countries, Merck KGaA, Darmstadt, Germany, has also partnered with Universal Corporation Ltd., Nairobi, Kenya.
In parallel, within the Consortium, the implementation research program (ADOPT) is currently ongoing, 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 at an at-cost basis in sub-Saharan African countries.
The collaborative program on arpraziquantel is part of the integrated approach of Merck KGaA, Darmstadt, Germany, to contribute to the elimination of schistosomiasis as a public health problem. Indeed, through its Schistosomiasis Elimination Program, Merck KGaA, Darmstadt, Germany, addresses the key requirements of the WHO’s 2021-2030 Roadmap for Neglected Tropical Diseases and contributes to the United Nations’ Sustainable Development Goals, especially Good Health and Well-Being (Goal 3) and Partnerships (Goal 17). The program also aligns with the Sustainability Strategy of Merck KGaA, Darmstadt, Germany, and the company’s commitment to expand sustainable and equitable access to medicines by bringing its existing products and innovative portfolio to patients in low- and middle-income countries recognizing the needs and the specificity of the health systems in each of the country.