Posted from: Thursday, March 07, 2019 - 10:28 AM - Present

Egaten Approved to Treat Fascioliasis

February 13, 2019 – The U.S. FDA has approved Egaten® (triclabendazole) tablets, manufactured by Novartis, to treat a form of liver flukes known as fascioliasis in patients who are at least six years old.

Fascioliasis occurs when parasitic flatworms belonging to the Fasciolidae family infect a host. The disease is found on all continents except Antarctica, but is most prevalent in developing nations. According to the CDC, infection typically follows the consumption of raw watercress or other water plants contaminated with immature parasite larvae.

According to a press release, FDA approval for Egaten may help facilitate drug licensing and import to countries in need. Novartis has worked with the World Health Organization (WHO) since 2005 to distribute the drug, and has pledged to continue donating supplies annually through 2022. WHO provides the treatment in areas where fascioliasis is endemic, or where an epidemic outbreak has occurred. 

Recommended dosing with Egaten is two 10mg/kg doses given 12 hours apart with food. The tablets are scored so that they can be cleanly divided, and come in a 250mg dosage strength. The dose should be rounded up if tablets cannot be divided to reach the exact dose calculated by patient’s weight.

 Launch and pricing plans for Egaten in the United States have not been announced.

Last Updated Friday, October 18, 2019 - 12:52 AM.