fda-approval-letter
PHARMACY

Novartis gets FDA nod for Egaten

BY Sandra Levy

Novartis has received the Food and Drug Administration’s clearance for Egaten (triclabendazole) for the treatment of fascioliasis in patients six years of age and older.

Egaten is 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, the company said.

“Novartis has a long-standing commitment to addressing global health challenges and supporting disease elimination efforts, in diseases such as leprosy, malaria and fascioliasis,” Novartis CEO Vas Narasimhan said. “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.”

Fascioliasis, or liver fluke infestation, is a neglected tropical disease that infects 2.4 million people worldwide, with an additional 180 million at risk of infection, Novartis said.

The disease is caused by two species of parasitic flatworms that can infect humans following ingestion of larvae in contaminated water or food.

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