FDA approves Novartis’ Egaten for parasitic infection fascioliasis

pharmafile | February 14, 2019 | News story | Sales and Marketing Egaten, FDA, Novartis, fascioliasis, pharma 

The FDA has taken the decision to authorise the use of Novartis’ Egaten (triclabendazole) in patients older than six years old for the treatment of fascioliasis, a disease contracted through ingestion of parasite larvae in infected water or food that can lead to considerable pain accompanied by fever, nausea and eosinophilia.

The move makes Egaten the first and only drug approved in the US for this indication, and the authorisation is expected to improve availability of treatment for affected patients even beyond the US in affected countries around the world; the condition is thought to affect 2.4 million people worldwide.

According to Novartis, Egaten is the only medicine for the condition recommended by the World Health Organization, and the company has been donating the drug to the organisation since 2005 in a bid to treat around two million affected patients in over 30 countries.  

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

Dr Mwelecela Malecela, Director of the Department of Control of Neglected Tropical Diseases at the WHO, also commented: “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.”

Matt Fellows

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