First treatment of Fascioliasis—— Egaten
February 15, 2019 - Swiss pharmaceutical giant Novartis has announced that the U.S. Food and Drug Administration (FDA) has approved Egaten (Triclabendazole) for the treatment of Fascioliasis (Fascioliasis) in patients 6 years of age and older.The approval makes Egaten the only FDA-approved drug for the treatment of tablet form of paragonimiasis and is expected to contribute to wider access to this important drug in the United States and affected countries worldwide.The approval of Egaten, which has been recognized by the FDA as a neglected tropical disease, also triggered the grant of a priority review certificate (PRV) based on that approval.
Vas Narasimhan, Chief executive of Novartis, said: "Novartis has a long-standing commitment to addressing global health challenges, supporting eradication efforts in diseases such as leprosy, malaria and chiromatosis.Today, the FDA's approval of Egaten is another important milestone that we believe will help further expand access to this one day only medication and move us one step closer to disease elimination."
Fascioliasis, commonly known as liver fluke infection, is a neglected tropical disease that infects 2.4 million people worldwide, with another 180 million at risk.The disease is caused by the ingestion of larvae from contaminated water or food (mainly unprocessed or undercooked plants) of two parasitic flatworms (fasciola hepatica and fasciola hepatica) that primarily affect the liver.More than 70 countries have reported cases of fasciolosis worldwide.
If left untreated, chirotomiasis can cause considerable pain and discomfort, leading to a lower quality of life and reduced productivity.The acute phase is characterized by fever, abdominal pain, nausea, diarrhea, and eosinophilia.The disease then progresses to an incubation period with fewer symptoms and eventually to a chronic or obstructive period.In children, paragonimiasis may be a severe infection with high fever, enlarged liver, and anemia.
Egaten is currently the only drug recommended by the World Health Organization (WHO) for the treatment of tablet form of paragonimiasis and has been included in the WHO model list of essential drugs.The drug is provided by WHO during epidemic outbreaks and is periodically used in endemic countries.The APPROVAL of Egaten by the FDA is expected to help promote drug licensing and import from these countries and help ensure that adequate and timely medicines are available when needed.
Novartis has donated Egaten to the WHO since 2005, helping to treat about 2 million patients with name card paragonimiasis in more than 30 countries.In 2018, Novartis renewed its agreement with the WHO to extend drug donations to 2022, with an estimated 300,000 patients a year.
Dr Mwelecela Malecela, director of the WHO's Neglected Tropical Disease Control Division, said: "This DECISION by the FDA is great news for millions of people WHO have or are at risk of chirotomiasis and could remove a major obstacle to the expansion of treatment to the countries most in need.We are grateful for Novartis's continued 10-year commitment to address another disease of poverty."(Bioon.com)
