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The United States Food and Drug Administration (FDA) has approved triclabendazole (Egaten, Novartis) to treat fascioliasis in patients 6 years of age and older.
Fasciolase (also called liver fluke infestation) is a waterborne and foodborne zoonotic disease caused by two species of parasitic worms. Fascioliasis is a neglected tropical disease that affects 2.4 million people worldwide and 180 million more people.
Triclabendazole is the only drug approved in the United States for the treatment of fascioliasis and is currently the only treatment recommended by the World Health Organization (WHO).
Triclabendazole is on the WHO Model List of Essential Medicines and is provided by the organization during epidemics and for its periodic use in endemic countries.
Approval of this drug by the FDA should facilitate broader access to the drug, not only in the United States, but also in affected countries around the world, Novartis said in a press release.
"This FDA decision is good news for millions of people suffering or at risk of fascioliasis, it eliminates a major obstacle to scaling up treatment to the countries where it is needed most," said Mwelecela Malecela , director of the Department of NTD control at the WHO, said in the statement. "We are grateful to Novartis for its sustained commitment for a decade in the fight against another disease of poverty."
Since 2005, Novartis has donated triclabendazole to WHO, treating approximately two million patients with fascioliasis in more than 30 countries. Last year, the company renewed its agreement with the WHO to extend the donation of drugs until 2022.
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