Egaten is claimed to be the only FDA-approved drug to treat fascioliasis, which is a neglected tropical disease.
Fascioliasis, which is commonly known as liver fluke infestation, is said to infect 2.4 million people across the globe and additional 180 million people are expected to be in danger with the disease.
The disease is induced by two species of parasitic flatworms, which can infect humans following ingestion of larvae in contaminated water or food.
Novartis CEO Vas Narasimhan 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.
“Today’s FDA approval of Egaten is another important milestone that we believe will help further expand access.
Egaten is also said to be the only drug for fascioliasis recommended by the World Health Organization (WHO). It is also included in the WHO Model List of Essential Medicines.
WHO will supply the drug during epidemic outbreaks,, as well as for periodic use in endemic countries.
The FDA approval will allow Novartis to secure drug license for Egaten and import to these countries. Since 2005, Novartis has been donating Egaten to the WHO, enabling to treat around two million fascioliasis patients in over 30 countries.
Last year, Novartis renewed its agreement with the WHO to extend the drug donation until 2022.
Novartis is also a signatory to the London Declaration on Neglected Tropical Diseases, which intends to control or eradicate 10 diseases by 2020.
WHO neglected tropical diseases department control director Mwelecela Malecela 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.”