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The US Food and Drug Administration (FDA) has announced that it has approved Egaten® (triclabendazole) for the treatment of fascioliasis in patients 6 years of age and older.
This FDA announcement is important because Egaten is now the only drug approved by the FDA for people with fascioliasis.
Fasciolase, known as the liver fluke infestation, is a neglected tropical disease that infects 2.4 million people worldwide and an additional 180 million people at risk of infection, the report says. Center for Disease Control and Prevention.
It is caused by two species of parasitic worms that can infect humans after ingesting larvae in water or contaminated food.
The FDA recognizes that fascioliasis is a neglected tropical disease, resulting in the granting of a priority review warrant based on this approval.
Egaten is currently the only drug against fascioliasis recommended by the World Health Organization (WHO) and is on the WHO Model List of Essential Drugs.
The diet recommended by Egaten is 10 mg / kg of body weight administered in a single dose, both in clinical practice and in preventive chemotherapy, according to the WHO.
The WHO provides Egaten with outbreaks and for periodic use in endemic countries. Human cases of fascioliasis have been reported in more than 70 countries worldwide.
Novartis has donated Egaten to the WHO since 2005, helping to treat about 2 million patients with fascioliasis in more than 30 countries.
In 2018, Novartis renewed its agreement with the WHO to extend the donation of drugs until 2022, which is expected to reach 300,000 patients a year.
Vas Narasimhan, CEO of Novartis, said in a press release: "Today 's approval of Egaten by the FDA is another milestone that we believe will contribute to to further expand access to this treatment one day, bringing us closer to the elimination of the disease. "
The Novartis Institute of Tropical Diseases, founded in 2001, is dedicated to finding new drugs to treat neglected diseases. Novartis is a signatory to the London Declaration on Neglected Tropical Diseases, which aims to control, eliminate or eradicate 10 diseases by 2020.
In addition to malaria, Novartis' research currently focuses on parasitic diseases such as cryptosporidiosis (diarrheal disease) and three major kinetoplastid diseases: human African trypanosomiasis (sleeping sickness), Chagas disease and leishmaniasis.
For more information, visit Novartis.
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