US FDA (Food and Drug Administration) has approved Egaten® (triclabendazole) for the treatment of fascioliasis.
It can be used by patients with 6 years of age and older. It is the only drug available approved by FDA against fascioliasis. It is recommended dose is 2 dose of 10mg/kg body weight given after every 12 hours orally. It can be taken with food.
It is contraindicated in patients with known hypersensitivity to triclabendazole and/or to other benzimidazole derivatives.
Fascioliasis is caused by parasitic flatworms or trematodes caused by two parasites F.hepatica and F. gigantica which affects the liver. It is mainly transferred through water or food. Till now, it affected 2.4 million people worldwide. An outbreak in northern Iran in 1989 and 1991 affected more than 10,000 people.
Vas Narasimhan, CEO of Novartis, “Novartis has a long-standing commitment to addressing global health challenges and supporting disease elimination efforts, in diseases such as leprosy, malaria and fascioliasis. 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 drug recommended by the WHO (World Health Organization) and is on the WHO Model List of Essential Medicines, the company states. It is supplied by WHO during epidemic outbreaks and for periodic use in endemic countries. Novartis has been donating to WHO since 2005, helping more than 2 million people in 30 countries. FDA approval of Egaten is expected to facilitate drug licensing and import to these countries.
No information is available to use in pregnant women. It can be stored in the original container below 30°C (86°F). It is available with a pack of 4 tablets.