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The world's first medicine formulated to treat a damaging tropical parasite infection in preschool children received the green light Friday from Europe's drug agency.
Schistosomiasis, also known as bilharzia, is a disease caused by parasitic worms that live in certain types of freshwater snails and kills some 20,000 people annually, according to the World Health Organization.
"The European Medicines Agency... has adopted a positive scientific opinion" for a medicine made by German-based pharmaceutical firm Merck to treat bilharzia in children from three months to six years, the Amsterdam-based EMA said.
Called "Arpraziquantel", the pill is intended for use outside the European Union under the EU-M4all procedure that aimed to give access to essential medicines in low- and middle-income countries.
This procedure saw the EMA combining its scientific review capabilities, the WHO's epidemiology and disease expertise, and help from national regulators to approve delivery of much-needed treatments.
More than 230 million people required preventative treatment for bilharzia in 2021 and in terms of its impact, it was second only to malaria as one of the world's most devastating parasitic diseases, the US Centers for Disease Control (CDC) said.
"Arpraziquantel is the first medicine formulated to meet the needs of preschool-aged children," added the EMA.
It will come in a 150mg tablet which dispersed in a cup of water, had a taste "acceptable for young children and withstood the hot environment of a tropical climate," it said in a statement.
Considered a "neglected tropical disease", bilharzia parasites enter the body through the skin when people waded, bathed, swam or washed in contaminated water containing certain freshwater snails in which the parasites hatched.
Within several weeks, the parasites developed into adult worms that lived in the blood vessels of the body where females produced eggs.
Some eggs then traveled to the bladder or intestine and were passed through urination or stool.
Infection can damage the liver, intestines, lungs and bladder and children who were repeatedly infected could develop anemia (shortage of red blood cells) and learning difficulties.
"Rarely, eggs are found in the brain or spinal cord and can cause seizures, paralysis, or spinal cord inflammation," the CDC said.
Arpraziquantel induced muscular paralysis in the worms, causing them to lose their grip inside veins.
"Instead, they migrate to the liver, where they are eventually destroyed and eliminated," the EMA said.
© 2023 AFP
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