Novartis announced that the Food and Drug Administration (FDA) has approved Egaten (triclabendazole) for the treatment of fascioliasis (also known as liver fluke infestation) in patients aged 6 years and older, making it the only FDA-approved treatment for this tropical disease.
Egaten, an anthelmintic, exhibits its effect against the Fasciola species. Studies suggest that triclabendazole and its metabolites are absorbed by the tegument of the immature and mature worms, leading to a decrease of the resting membrane potential, inhibition of tubulin function, as well as protein and enzyme synthesis. These are associated with motility inhibition, surface disruption, and inhibition of spermatogenesis and vitelline cells.
Fascioliasis is caused by 2 species of parasitic flatworms or tremtaodes that mainly affect the liver. Humans are infected after ingesting larvae contaminated in water or food, which mature into adult worms in the biliary tract. If untreated, the patient can experience fever, abdominal pain, nausea, diarrhea, and eosinophilia in the acute phase; the disease may progress to a latent phase and eventually into a chronic or obstructive phase.
Since 2005, Novartis has been donating Egaten to the World Health Organization. In 2018, the Company renewed an agreement to extend the donation until 2022. “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,” stated Vas Narasimhan, CEO of Novartis.
Egaten was previously granted Fast Track and Orphan Drug designations. It is supplied as 250mg strength tablets.
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