December 23, 2024

FDA approves Novartis’s Egaten® for the treatment of fascioliasis, a tropical disease

FDA approval
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By neucrad health February 17, 2019

Pharma giant “Novartis” (headquartered at Basel, Switzerland), announced yesterday that it has received the approval from FDA about the use of  Egaten® (triclabendazole) for the treatment of fascioliasis in patients six years of age and older. Egaten is currently the only medicine for fascioliasis recommended by the World Health Organization (WHO) and since 2005 has been used to treat around 2 million fascioliasis patients all over the world. Last year, Novartis extended its drug donation for Egaten®(triclabendazole) to WHO until 2022.

Fascioliasis, commonly known as liver fluke infestation, is a tropical disease that infects more than 2 million people worldwide with an additional 100 + million people at higher risks of infection. It is caused by two species of parasitic flatworms or trematodes (Fasciola hepatica or Fasciola gigantica) that mainly affect the liver. It belongs to the group of foodborne trematode infections where it can be transmitted to humans following ingestion of contaminated water or food. The common host is ruminants such as cattle and sheep. Fever, malaise, abdominal pain, gastrointestinal symptoms, urticaria, anemia, jaundice, and respiratory symptoms are manifested during the acute phase of disease progression. In the chronic state, the disease causes inflammation of the bile ducts, gall bladder and may also cause gallstones as well as fibrosis.

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

Image Credit: Shivali Duduskar, Doctoral Student of University of Jena