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The approval expands use of the drug, Egaten (triclabendazole), which has been by the WHO since 2005 for treating liver fluke infestation.
Novartis announced on Feb. 13, 2019, that FDA has approved Egaten (triclabendazole) for treating fascioliasis, a neglected tropical disease commonly known as liver fluke infestation, in patients six years of age and older. This marks the first FDA-approved drug for this disease, Novartis claimed in its press release.
Novartis’ drug is currently the only medicine for fascioliasis recommended by the WHO and is on the WHO Model List of Essential Medicines, the company states. 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. Fascioliasis is recognized by FDA as a neglected tropical disease, triggering a priority review designation voucher based on 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. The company renewed its agreement with the WHO in 2018 to extend the drug donation until 2022, expected to reach 300 000 patients per year.
"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, in the company press release. "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."
"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," said Dr. Mwelecela Malecela, director of the Department of Control of Neglected Tropical Diseases at the WHO, in the press release. "We are thankful to Novartis for their sustained decade-long commitment in tackling yet another disease of poverty."