EMA validates application for arpraziquantel to treat schistosomiasis

Today, the Pediatric Praziquantel Consortium announced that the European Medicines Agency (EMA) has validated for review the application for arpraziquantel for the treatment of schistosomiasis in preschool-aged children (three months to six years of age), submitted by its partner, German pharma and life sciences firm Merck KGaA (MRK: DE). With this validation, the regulatory application for arpraziquantel is complete and the EMA will now begin the scientific review process.

“With this milestone, we are one step closer to achieving our mission of improving the health of preschool-aged children with schistosomiasis. Our contribution forms part of our larger ambition to eliminate schistosomiasis as a public health burden by 2030,” said Peter Guenter, a member of the executive board and chief executive of Healthcare at Merck.

Merck submitted the application on behalf of the Consortium for a scientific opinion by the 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 is designated as the future Marketing Authorization Holder for African countries.