FDA, New Products

Donated globally since 2005, Novartis’ flatworm treatment Egaten wins FDA nod — and a PRV

Novartis $NVS has the fix for all your parasitic flatworm needs. The Swiss drugmaker developed a human treatment for fascioliasis in partnership with the WHO after formulating a similar medicine for domestic livestock who are also vulnerable to the neglected tropical disease, which has cropped up in more than 70 countries. Since 2005, the drugmaker has been donating the drug — Egaten — globally, and on Wednesday, the medicine was approved by the FDA.

Fascioliasis is caused by two species of leaf-shaped parasitic flatworms following ingestion of larvae in contaminated water or food — mainly raw or undercooked vegetation — and the larvae mature into adult worms in the liver. According to the WHO, the infection is present in domestic animals in almost every country where cattle and sheep are reared, and where livestock is affected, humans usually are too. The agency estimates at least 2.4 million people are infected globally, with several million at risk. Rare cases of the infection in the United States have been documented, and transmission due to imported contaminated produce could occur, as seen in Europe, the CDC has cautioned.

Mwelecela Malecela

Since 2005, Novartis has donated roughly 4 million tablets of Egaten (triclabendazole), valued at $41 million, facilitating the treatment of around 2 million people with fascioliasis in more than 30 countries, Novartis said last July as it renewed its commitment to donate the drug till December 2022. This pledge includes the donation of 600,000 tablets annually, which are expected to reach 300,000 patients per year.

The drug is recognized in the WHO’s model list of essential medicines, and is made available by the agency during epidemics and for periodic use in endemic countries. For instance, an outbreak in northern Iran in 1989 and 1991 affected more than 10,000 people, and others have occurred in Algeria, Cuba and France, according to the National Organization for Rare Disorders.

In the US, the CDC has long also considered the one-day treatment the drug of choice, making it available thus far in case of an infection under a special (investigational) protocol. But health regulators’ full endorsement of the drug for use in patients six years and older is expected to facilitate drug licensing and import to affected countries when needed, Novartis said, adding that the approval also triggered the award of a priority review voucher.

“This FDA decision…removes a major hurdle in expanding treatment to countries where it is most needed,” said Mwelecela Malecela, director of the department of control of neglected tropical diseases at the WHO.

The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 47,700+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

Visit Endpoints Careers ->