FDA Approves Triclabendazole for Treatment of Fascioliasis

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

The approval marks the first FDA-approved drug for this neglected tropical disease, which is commonly known as liver fluke infestation. Fascioliasis is caused by 2 species of parasitic flatworms, Fasciola hepatica or Fasciola gigantica, that can be transmitted to humans following consumption of larvae in contaminated water or food.

"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," Vas Narasimhan, CEO of Novartis, said in a statement.

Triclabendazole is currently the only medicine for fascioliasis recommended by the World Health Organization (WHO) and is supplied by WHO during epidemic outbreaks and for appropriate use in endemic countries. No continent is free from fascioliasis; human cases have been reported from more than 70 countries worldwide, infecting 2.4 million people, with an additional 180 million at risk of infection.

If left untreated fascioliasis can cause pain and discomfort, leading to decreased quality of life. Symptoms of the acute phase of the disease include fever, abdominal pain, nausea, diarrhea, and eosinophilia. The disease later progresses to a latent phase during which symptoms are not as severe, with a chronic or obstructive phase following. In children, fascioliasis can be a serious infection with high fever, enlarged tender liver, and anemia.

Novartis has been donating Egaten to the WHO since 2005 and has treated an estimated 2 million fascioliasis patients in more than 30 countries. In 2018, the company renewed its agreement with the WHO to extend the drug donation until 2022 and it’s estimated to reach 300,000 patients each year.

"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," said Dr Mwelecela Malecela, director of the Department of Control of Neglected Tropical Diseases at the WHO.

The approval of triclabendazole in the United States is expected to facilitate drug licensing and import to endemic countries, to helping provide sufficient availability of the drug when needed.