Novartis Receives FDA Approval for Egaten® (Triclabendazole), the First and Only Single-Day Treatment for Fascioliasis

Source:BioValley 2019-02-15 16:54

2019Year02Month15Daily News/Bio ValleyBIOON/ --Swiss pharmaceutical giant Novartis (Novartis) recently announced that the U.S. Food and Drug Administration (FDA) ApprovedEgaten（triclabendazole, triclabendazole), for6Patients aged ≥ years for the treatment of fascioliasis (fascioliasis). This approval enablesEgatenBecomeFDAthe only approved drug for the treatment of fascioliasis, and it is expected to help broaden access to this important medication in the United States as well as in affected countries worldwide. Fascioliasis has been recognized in the United StatesFDADesignated as a neglected tropical disease,Egatenapproval also triggered the priority review voucher based on such approval (PRV) of the grant.

CEO of NovartisVas Narasimhanstated, “Novartis has long been committed to addressing global health challenges and supporting eradication efforts for diseases such as leprosy, malaria, and fascioliasis. Today,”FDAYesEgatenapproval marks another important milestone, and we believe it will help further expand access to this one-day medication, bringing us one step closer to disease elimination.”

Fascioliasis (fascioliasis) commonly known as liver fluke infection, which is a neglected tropical disease infecting people globally24010,000 people, in addition to1.8Hundreds of millions of people are at risk of infection. The disease is caused by2caused by parasitic flatworms (Fasciola hepatica and Fasciola gigantica) that primarily affect the liver; humans become infected after ingesting larvae present in contaminated water or food (mainly unprocessed or undercooked plants). Worldwide, more than70countries reported cases of fascioliasis.

If not treated promptly, fascioliasis can cause significant pain and discomfort, leading to reduced quality of life and decreased productivity. The acute phase is characterized by fever, abdominal pain, nausea, diarrhea, and eosinophilia. The disease then progresses to a latent phase with fewer symptoms, eventually developing into the chronic or obstructive phase. In children, fascioliasis can be a severe infection accompanied by high fever, hepatomegaly, and anemia.

Egatenis currently the World Health Organization (WHO) the only drug recommended for the treatment of fascioliasis, and has been included inWHOModel List of Essential Medicines. This drug is manufactured byWHOProvided during epidemic outbreaks and periodically used in endemic countries.FDAYesEgatenapproval, which is expected to help facilitate drug licensing and importation in these countries, thereby helping to ensure an adequate and timely supply of medicines when needed.

Novartis since2005Since [year], has been continuously providing toWHODonationEgaten, help30Treatment in Multiple Countries Approximately200# Ten Thousand Cases of Fasciolopsiasis.2018In [year], Novartis updated its agreement withWHOthe agreement, extending the drug donation period to2022per year, expected to reach annually3010,000 patients.

WHODirector, Department of Control of Neglected Tropical DiseasesMwelecela MalecelaThe doctor stated, “ThisFDAThis decision is welcome news for the millions of people suffering from or at risk of fascioliasis, as it promises to remove a major barrier to expanding treatment to the countries most in need. We thank Novartis for its decade-long commitment to addressing another neglected tropical disease.” (BioonBioon.com）

Original source:Novartis receives FDA approval for Egaten® for the treatment of fascioliasis, a neglected tropical disease