KENYA—Kenya has planned to use arpraziquantel to treat schistosomiasis in preschool-aged children after the European Medicines Agency (EMA) recommended it.
Arpraziquantel, derived from praziquantel, is an oral tablet that dissolves in the mouth. No new potential dangers or safety issues have been found.
Praziquantel, which was discovered in the 1970s, is now the standard medicine used to treat the condition.
Praziquantel, the current “standard of care” treatment for schistosomiasis, is delivered to adults and school-age children in Kenya through mass medication administration programs.
However, the medication is not appropriate for children under the age of six, which means that more than 50 million preschool-aged children worldwide are currently without effective treatment.
The new pill is small, has an appropriate taste, may be taken with or without water, and can resist the hot and humid conditions of a tropical climate.
The new medicine, which has been tested in clinical trials by the Kenya Medical Research Institute, has been shown to be effective and safe for children aged three months to six years.
KEMRI took part in the Phase III clinical trial of Pediatric Praziquantel (PZQ) at the Homa Bay Teaching and Referral Hospital.
KEMRI acting director general Prof. Elijah Songok stated that the institute is committed to confirming the potential of the new pediatric PZQ formulation and that he is proud to be a part of improved treatments for the country’s nearly 250,000 young children infected with schistosomiasis, one of the NTDs.
According to KEMRI, the new medicine has an acceptable flavor, making it more palatable to young children and increasing its pharmacological efficiency in treating schistosomiasis.
Merck served as a trial sponsor, ensuring that the relevant quality standards and regulatory requirements from authorities such as the EMA were met.
Dr. Jutta Reinhard-Rupp, chair of the Pediatric Praziquantel Consortium Board and head of Merck’s Global Health Institute, hailed the development, stating that after more than ten years of rigorous collaboration, we are happy to have obtained a positive scientific opinion from EMA.
She went on to explain that as collaborators, they have come a long way toward their goal of offering a treatment option for the most susceptible group—the youngest—and that this will help to reduce the worldwide disease burden of schistosomiasis.
Schistosomiasis, often known as bilharzia or snail fever, is a neglected tropical disease (NTD) that affects about 240 million people globally.
Schistosomiasis transmission remains a serious public health concern in Kenya, where the schistosoma parasite is endemic in 62 of the country’s 290 subcounties.
The three main endemic areas are the Coastal region, sections of the Central and Lower Eastern areas, and the Lake Victoria basin.
Transmission is still frequent in many locations, with people becoming infected while performing domestic, agricultural, or commercial activities.
Worm exposure can occur while car washing, sand gathering, fishing, or participating in recreational activities such as swimming.
Bilharzia is caused by parasitic flatworms known as schistosomes, the most common of which are Schistosoma mansoni and S. haematobium.
The parasites live in freshwater snails and infect humans by puncturing the skin.
The condition can cause chronic organ inflammation, which can be fatal, as well as anemia, stunted growth, and decreased learning ability, all of which have catastrophic effects on young children’s lives.
The EMA’s affirmative opinion now clears the way for arpraziquantel to be added to the World Health Organization’s list of prequalified medical products, as well as regulatory approval in endemic countries.