The FDA has approved triclabendazole (EGATEN, Novartis) for the treatment of fascioliasis in patients aged six years and older. This makes it the only drug approved by the agency for people with this disease.
Fascioliasis, or liver fluke infestation, is a neglected tropical disease that infects around 2.4 million people worldwide, and 180 million more people are at risk being infected. It is caused by two types of parasitic flatworms (Fasciola hepatica and Fasciola gigantica) that can infect humans after ingesting the larvae in contaminated water or food.
Fascioliasis causes significant pain and discomfort if it is untreated, leading to a poor quality of life. Fever, abdominal pain, nausea, diarrhea, and eosinophilia occur in the acute stage of the disease. Fascioliasis can prove serious in children, causing high fever, an enlarged tender liver, and anemia. The disease is found on every continent, and human cases have occurred in more than 70 countries worldwide.
Currently, triclabendazole is the sole treatment for fascioliasis recommended by the World Health Organization (WHO) and is included on their Model List of Essential Medicines. WHO supplies the drug during epidemic outbreaks and for use in endemic countries, and the new FDA approval should facilitate drug licensing and import to these countries.
Novartis has been donating triclabendazole to the WHO since 2005 and is a signatory to the London Declaration on Neglected Tropical Diseases, whose goal is to control or eradicate 10 diseases by 2020.
Source: Novartis, February 14, 2019