July 18, 2024

EU Regulator Approves Treatment for Bilharzia Parasite Infection in Children

The European Medicines Agency (EMA) has granted approval to German-based pharmaceutical firm Merck for a medicine designed to treat schistosomiasis, also known as bilharzia, in preschool children. Bilharzia is caused by parasitic worms that reside in certain types of freshwater snails and is responsible for approximately 20,000 deaths annually, according to the World Health Organization (WHO). The medicine, called Arpraziquantel, is intended for use outside the European Union under the EU-M4all procedure, which aims to provide access to essential medicines in low- and middle-income countries.

Bilharzia is considered a neglected tropical disease, with over 230 million people requiring preventative treatment in 2021. It is the second most devastating parasitic disease in the world, after malaria, according to the US Centers for Disease Control (CDC). Infection occurs when individuals come into contact with contaminated water containing freshwater snails that harbor the parasites. The parasites enter the body through the skin and mature into adult worms that reside in the blood vessels. Females produce eggs, some of which travel to the bladder or intestine and are expelled through urination or stool.

The infection can lead to damage in various organs, including the liver, intestines, lungs, and bladder. Children who experience recurrent infections may develop anemia and learning difficulties. In rare cases, eggs may be found in the brain or spinal cord, resulting in seizures, paralysis, or inflammation of the spinal cord, as noted by the CDC.

Arpraziquantel works by inducing muscular paralysis in the worms, causing them to detach from the veins where they reside. It is the first medicine specifically formulated to cater to the needs of preschool-aged children, as stated by the EMA. The medicine is available in a 150mg tablet that can be easily dissolved in water. It has a taste that is acceptable to young children and is resistant to the hot climate of tropical regions.

The approval of Arpraziquantel through the EU-M4all procedure demonstrates the collaborative efforts of the EMA, WHO, and national regulators. By combining scientific review capabilities, disease expertise, and regulatory support, this procedure enables the timely delivery of crucial treatments to areas in need. The adoption of this anti-bilharzia medicine represents a significant step in combating the global burden of schistosomiasis, particularly among vulnerable populations such as preschool-aged children.

Bilharzia is a debilitating disease that affects millions of individuals worldwide, and the availability of an effective treatment for young children is a significant advancement. The approval of Arpraziquantel provides hope for the prevention and management of bilharzia infections, ultimately contributing to improved health outcomes and a reduction in mortality associated with this neglected tropical disease. As efforts continue to address the global burden of parasitic diseases, it is crucial to prioritize access to essential medicines and ensure their availability in regions heavily impacted by these diseases.

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1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it