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Novartis’ Egatan gains US approval for neglected tropical disease

US approval removes barrier to greater access


The FDA has given its seal of approval to Novartis’ Egatan, which becomes the first approved treatment in the US for tropical disease fascioliasis.

Most commonly known as liver fluke infestation, the disease is caused by two species of parasitical flatworms found in contaminated water or food, and is estimated to affect 2.4m people in some of the world's poorest regions.

The drug's active ingredient triclabendazole went off patent in the 1990s, but Novartis' drive to gain FDA approval is being hailed as a major step forward in broadening its availability in the regions where it is needed most.

Fasciola hepatica is found in more than 70 countries, including certain regions of Latin America, the Caribbean, Europe, the Middle East, Africa, Asia, and Oceania. Fasciola gigantica is found in fewer global regions, though human cases have been reported in the tropics, Africa and Asia and Hawaii.

Left untreated, the infestations can result in considerable pain and discomfort, leading to poor quality of life and loss of productivity.

It is approved for those aged six years and older, and Novartis has confirmed that it expects an even bigger rollout of this drug following the approval, with “disease elimination” being the end goal.

“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 (below).


“Today’s FDA approval of Egaten is another important milestone that we believe will help further expand access to this one-day treatment.”

Novartis has long been donating the drug to the WHO, which supplies the drug for periodic use in endemic countries during epidemic outbreaks, and Novartis has recently renewed the agreement that will allow WHO continued access until 2022.

Since the start of the donation programme, Egatan has treated around 2m patients in more than 30 countries and as a result the drug made its way onto the WHO Model List of Essential Medicines.

“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.

"We are thankful to Novartis for their sustained decade-long commitment in tackling yet another disease of poverty."

Article by
Gemma Jones

14th February 2019

From: Regulatory



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