Novartis receives FDA approval for Egaten ® a fascioliasis drug

Novartis has received FDA approval for Egaten

Novartis has received FDA approval for Egaten ® (triclabendazole) for the treatment of fascioliasis is 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.

Fascioliasis, commonly known as liver fluke infestation, is a neglected tropical disease that infects 2.4 million people worldwide, with an additional 180 million at risk of infection. It is caused by two species of parasitic flatworms that can infect humans following ingestion of larvae in contaminated water or food.

Fascioliasis is caused by two species of parasitic flatworms or trematodes that mainly affect the liver (Fasciola hepatica or Fasciola gigantica). Both species can infect humans following ingestion of larvae in contaminated water or food (mainly raw or undercooked vegetation). Left untreated, fascioliasis can result in considerable pain and discomfort, leading to poor quality of life and loss of productivity. The acute phase of the disease is manifested with fever, abdominal pain, nausea, diarrhoea and eosinophilia.

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 recognised by the FDA as a neglected tropical disease, triggering the award of a Priority Review Voucher based upon this approval.

Novartis has been donating Egaten to the WHO since 2005, helping to treat around 2 million fascioliasis patients in more than 30 countries. In 2018, Novartis renewed their agreement with the WHO to extend the drug donation until 2022, expected to reach 300 000 patients per year.

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

Dr Mwelecela Malecela, Director of the Department of Control of Neglected Tropical Diseases at the WHO said, “This FDA decision is welcome news for millions who suffer or are at risk of fascioliasis and removes a major hurdle in expanding treatment to countries where it is most needed. We are thankful to Novartis for their sustained decade-long commitment in tackling yet another disease of poverty.”