FDA Approves Egaten for the Treatment of ‘Fluke Infestation’

The US Food and Drug Administration (FDA) announced it has approved Egaten® (triclabendazole) for the treatment of fascioliasis, in patients 6 years of age and older. 

This FDA announcement is important since Egaten is now the only FDA-approved drug for people with fascioliasis. 

Fascioliasis, commonly known as liver fluke infestation, is a neglected tropical disease that infects 2.4 million people worldwide, with an additional 180 million at risk of infection, says the Centers for Disease Control and Prevention. 

It is caused by two species of parasitic flatworms that can infect humans following ingestion of larvae in contaminated water or food. 

Fascioliasis is recognized by the FDA as a neglected tropical disease, triggering the award of a Priority Review Voucher based upon this approval. 

Egaten is currently the only medicine for fascioliasis recommended by the World Health Organization (WHO) and is on the WHO Model List of Essential Medicines. 

The recommended Egaten regimen is 10 mg/kg body weight administered as a single dose in both clinical practice and preventive chemotherapy interventions says the WHO. 

The WHO supplies Egaten during epidemic outbreaks and for periodic use in endemic countries. Human cases of fascioliasis have been reported from more than 70 countries worldwide. 

Novartis has been donating Egaten to the WHO since 2005, helping to treat around 2 million fascioliasis patients in more than 30 countries. 

In 2018, Novartis renewed its WHO agreement to extend the drug donation until 2022, expected to reach 300,000 patients per year. 

Vas Narasimhan, CEO of Novartis said in a press release, "Today's FDA approval of Egaten is another important milestone that we believe will help further expand access to this one-day treatment, taking us a step closer toward disease elimination." 

The Novartis Institute for Tropical Diseases, founded in 2001, is dedicated to finding new medicines 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. 

To learn more, visit Novartis.