Novartis receives FDA approval for Egaten for the treatment of fascioliasis, a neglected tropical disease

Novartis International AG / Novartis receives FDA approval for Egaten for the treatment of fascioliasis, a neglected tropical disease . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• Egaten is the only drug approved in the US for the treatment of people with fascioliasis and is currently the only treatment recommended by the WHO
   

Fascioliasis, commonly known as liver fluke infestation, is estimated to infect 2.4 million people globally[1]
 

Novartis has been donating Egaten to the WHO since 2005, helping to treat around 2 million patients in more than 30 countries
 

FDA approval reinforces the company's commitment to reduce the burden of neglected tropical diseases including fascioliasis, leprosy and malaria

Basel, Switzerland, February 13, 2019 - Novartis announced today that the US Food and Drug Administration (FDA) has approved Egaten (triclabendazole) for the treatment of fascioliasis in patients six years of age and older. This makes Egaten the only FDA-approved drug for people with this disease and is expected to facilitate broader access to this important drug not only in the US, but also in affected countries worldwide.

"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. "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."

Fascioliasis, commonly known as liver fluke infestation, is a neglected tropical disease that infects 2.4 million people worldwide[1], with an additional 180 million at risk of infection[2]. It is caused by two species of parasitic flatworms that can infect humans following ingestion of larvae in contaminated water or food.

Egaten is currently the only medicine for fascioliasis recommended by the WHO and is on the WHO Model List of Essential Medicines. 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, helping ensure sufficient and prompt availability of the drug when needed. Fascioliasis is recognized by the FDA as a neglected tropical disease, triggering the award of a Priority Review Voucher based upon this approval.