Novartis secures FDA approval for Egaten as fascioliasis treatment

Novartis has achieved a significant milestone with the FDA’s approval of Egaten (triclabendazole) for the treatment of fascioliasis in patients aged six years and older. This makes Egaten the only FDA-approved drug for treating the neglected tropical disease, which affects millions worldwide.

Fascioliasis, caused by parasitic flatworms Fasciola hepatica and Fasciola gigantica, typically spreads through the consumption of contaminated water or food containing larvae. The disease is most common in regions with poor sanitation, impacting both rural and urban populations. The approval of Egaten offers a beacon of hope for those suffering from this debilitating disease, with Novartis working to enhance its global accessibility.

A critical step toward global disease elimination

Egaten’s approval by the FDA is poised to be a game changer in the fight against fascioliasis. The drug’s accessibility will not only expand within the United States but is expected to be a critical tool for affected countries globally. According to Vas Narasimhan, CEO of Novartis, the approval aligns with the company’s long-standing commitment to addressing neglected tropical diseases. Narasimhan emphasized that this approval represents a key step in Novartis’ journey to support global health initiatives and disease elimination efforts, which already include major contributions to the treatment of diseases such as leprosy and malaria.

The FDA approval strengthens Egaten’s position as the only drug recommended by the World Health Organization (WHO) for the treatment of fascioliasis. It is also listed on the WHO Model List of Essential Medicines, highlighting its importance in public health efforts. The WHO has been a vital partner in distributing the drug, supplying it during outbreaks and in endemic countries for periodic use.

Boosting global access to treatment

With the FDA approval now in place, the logistics of drug licensing and importation will be streamlined, making Egaten more readily available in countries where fascioliasis is most prevalent. This move ensures that the drug can reach affected populations quickly and efficiently, especially during outbreaks or in high-risk regions.

Since 2005, Novartis has been at the forefront of addressing fascioliasis by donating Egaten to the WHO. The company’s contributions have aided in the treatment of approximately 2 million patients across over 30 countries. A renewed agreement between Novartis and the WHO will extend this support until 2022, with plans for Egaten to treat 300,000 patients annually.

Expert opinions: A positive step for neglected diseases

Dr. Mwelecela Malecela, Director of the Department of Control of Neglected Tropical Diseases at the WHO, welcomed the FDA’s decision, noting that it removes a major barrier in the fight against fascioliasis. Malecela stated that the approval will significantly enhance treatment accessibility in areas where the disease burden is highest. The WHO expressed gratitude to Novartis for its decade-long commitment to addressing diseases of poverty and improving global health.

A major milestone for Novartis and global health

The FDA approval of Egaten marks a major victory in the battle against neglected tropical diseases. Novartis’ continued dedication to disease elimination and its collaborative work with global health organizations such as the WHO underscore the potential for significant public health improvements. As the only approved treatment for fascioliasis, Egaten’s global reach and availability could be a decisive factor in reducing the burden of this neglected disease, bringing hope to millions at risk.