parasitic diseases in humans

parasitic diseases in humans

FDA Approves Egaten for the Treatment of ‘Fluke Infestation’ - PrecisionVaccinations

Posted: 16 Feb 2019 12:00 AM PST

The US Food and Drug Administration (FDA) announced it has approved Egaten® (triclabendazole) for the treatment of fascioliasis, in patients 6 years of age and older. 

This FDA announcement is important since Egaten is now the only FDA-approved drug for people with fascioliasis. 

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, says the Centers for Disease Control and Prevention. 

It is caused by two species of parasitic flatworms that can infect humans following ingestion of larvae in contaminated water or food. 

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

Egaten is currently the only medicine for fascioliasis recommended by the World Health Organization (WHO) and is on the WHO Model List of Essential Medicines. 

The recommended Egaten regimen is 10 mg/kg body weight administered as a single dose in both clinical practice and preventive chemotherapy interventions says the WHO. 

The WHO supplies Egaten during epidemic outbreaks and for periodic use in endemic countries. Human cases of fascioliasis have been reported from more than 70 countries worldwide. 

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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 its WHO agreement to extend the drug donation until 2022, expected to reach 300,000 patients per year. 

Vas Narasimhan, CEO of Novartis said in a 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." 

The Novartis Institute for Tropical Diseases, founded in 2001, is dedicated to finding new medicines to treat neglected diseases. Novartis is a signatory to the London Declaration on Neglected Tropical Diseases, which aims to control, eliminate or eradicate 10 diseases by 2020. 

In addition to malaria, Novartis research currently focuses on parasitic diseases such as cryptosporidiosis (diarrheal disease) and three major kinetoplastid diseases: human African trypanosomiasis (sleeping sickness), Chagas disease and leishmaniasis. 

To learn more, visit Novartis.

FDA clears liver-fluke disease therapy Egaten, Novartis collects PRV - BioWorld Online

Posted: 14 Feb 2019 06:56 AM PST

By Randy Osborne, Staff Writer

After having donated the benzimidazole therapy to the World Health Organization (WHO) since 2005 as a way of helping to treat about 2 million patients in more than 30 countries, Novartis AG won approval by the FDA of Egaten (triclabendazole) for fascioliasis, or liver-fluke disease, in patients six years of age and older.

Globally, fascioliasis is estimated to affect about 2.4 million people, with about 180 million more at risk, and Egaten is now the only drug cleared by U.S. regulators for the condition as well as the only remedy endorsed by the WHO. In 2018, Basel, Switzerland-based Novartis renewed its agreement with the WHO to extend the drug donation program until 2022, and Egaten is expected to reach 300,000 patients per year.

The action by the FDA bags Novartis a priority review voucher (PRV), since fascioliasis is recommended by the WHO as a neglected tropical disease. Provided by the WHO during epidemic outbreaks and for periodic use in endemic countries, Egaten with FDA approval is expected to become more readily available for licensing and import to these countries, thus ensuring sufficient and prompt supply as needed, Novartis said.

Fascioliasis is caused by two species of parasitic flatworms or trematodes that mainly affect the liver (Fasciola hepatica or Fasciola gigantica). Both can infect humans who eat larvae in contaminated water or food, mainly raw or undercooked vegetation, and the larvae mature into adult worms in the biliary tract. No continent is without the disease, and human cases have been reported from more than 70 countries.

If left untreated, fascioliasis can result in considerable pain, poor quality of life and loss of productivity, with the acute phase of the disease showing up in symptoms such as fever, abdominal pain, nausea, diarrhea and eosinophilia. The disease eventually progresses to a latent phase with fewer symptoms, and then into a chronic or obstructive phase. Afflicted children can develop a serious infection with high fever, enlarged tender liver and anemia.

Novartis is part of the London Declaration on Neglected Tropical Diseases, which aims to control, eliminate or eradicate 10 diseases by 2020. The Novartis Institute for Tropical Diseases, founded in 2001, has research ongoing that's directed at parasitic diseases such as cryptosporidiosis (diarrheal disease) and three major kinetoplastid diseases: human African trypanosomiasis (sleeping sickness); Chagas disease; and leishmaniasis. The company also has efforts underway to target access to medicine for chronic diseases and, most recently, to fight sickle cell disease in Africa, starting in Ghana.

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