13 February 2019 - Egaten is the only drug approved in the US for the treatment of people with fascioliasis and is currently the only treatment recommended by the WHO.
Novartis announced today that the US FDA has approved Egaten (triclabendazole) for the treatment of fascioliasis in patients six years of age and older. This makes Egaten the only FDA-approved drug for people with this disease and is expected to facilitate broader access to this important drug not only in the US, but also in affected countries worldwide.
Egaten is currently the only medicine for fascioliasis recommended by the WHO and is on the WHO Model List of Essential Medicines. It is supplied by WHO during epidemic outbreaks and for periodic use in endemic countries. FDA approval of Egaten is expected to facilitate drug licensing and import to these countries, helping ensure sufficient and prompt availability of the drug when needed. Fascioliasis is recognized by the FDA as a neglected tropical disease, triggering the award of a Priority Review Voucher based upon this approval.