Merck KGaA announces positive phase III results for arpraziquantel as part of its schistosomiasis elimination program
Merck KGaA, a leading science and technology company, and the Pediatric Praziquantel Consortium, announced that the EMA has validated for review the application for arpraziquantel for the treatment of schistosomiasis in preschool-aged children (3 months to 6 years of age)
The application was submitted by Merck on behalf of the Consortium for a scientific opinion by EMA under the EU-M4all procedure for high-priority medicines for human use intended for markets outside the European Union. A positive scientific opinion by EMA, if received, will facilitate regulatory decisions in endemic countries.
Merck KGaA is designated as the future Marketing Authorization Holder for African countries.
For next steps, the Consortium is preparing for the potential inclusion of arpraziquantel in the World Health Organization list of prequalified and essential medicinal products. Together with relevant stakeholders, it is also exploring new mechanisms for providing equitable and sustainable access to arpraziquantel, once registered, and is conducting ADOPT – an implementation research program that paves the way for the large-scale delivery in endemic countries. The aim is to start the launch phases in 2024 for product availability on a not-for-profit basis in initial sub-Saharan African countries..
In addition to Farmanguinhos in Brazil, Merck has also partnered with Universal in Kenya for extensive local production capacities for endemic African countries.
Derived from praziquantel, the standard of care treatment developed in the 1970s, arpraziquantel is tailored to meet the needs of preschool-aged children suffering from schistosomiasis. This group of approximately 50 million patients currently lacks a suitable treatment option. Containing the pharmacologically active enantiomer of praziquantel, arpraziquantel is a novel dispersible or orodispersible tablet (150mg). It can be taken with or without water, is palatable for preschool-aged children, and withstands hot and humid challenges presented by a tropical climate.
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