FDA OKs Triclabendazole (Egaten) for Neglected Tropical Disease Fascioliasis

Megan Brooks

February 15, 2019

The US Food and Drug Administration (FDA) has approved triclabendazole (Egaten, Novartis) to treat fascioliasis in patients aged 6 years or older.

Fascioliasis (also known as liver fluke infestation) is a waterborne and foodborne zoonotic disease caused by two species of parasitic flatworms. Fascioliasis is a neglected tropical disease with an estimated 2.4 million cases worldwide and an additional 180 million people at risk.

Triclabendazole is the only drug approved in the United States for fascioliasis and is currently the only treatment recommended by the World Health Organization (WHO).

Triclabendazole is on WHO's Model List of Essential Medicines and is supplied by the organization during epidemic outbreaks and for periodic use in endemic countries.

The FDA approval of this drug is expected to facilitate broader access to the drug not only in the United States but also in affected countries worldwide, Novartis said in a news release.

"This FDA decision is welcome news for millions who suffer or are at risk of fascioliasis and removes a major hurdle in expanding treatment to countries where it is most needed," Mwelecela Malecela, director of the Department of Control of Neglected Tropical Diseases at WHO, said in the release. "We are thankful to Novartis for their sustained decade-long commitment in tackling yet another disease of poverty."

Since 2005, Novartis has been donating triclabendazole to WHO, leading to treatment of about two million fascioliasis patients in over 30 countries. Last year, the company renewed its agreement with WHO to extend the drug donation until 2022.

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