Egaten FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 27, 2019.
FDA Approved: Yes (First approved February 13, 2019)
Brand name: Egaten
Generic name: triclabendazole
Dosage form: Tablets
Company: Novartis Pharmaceuticals Corporation
Treatment for: Fascioliasis
Egaten (triclabendazole) is a benzimidazole anthelmintic indicated for the treatment of fascioliasis, a neglected tropical disease (NTD) caused by liver flukes Fasciola hepatica and Fasciola gigantica.
Dosage and Administration
- The recommended dose of Egaten is two doses of 10 mg/kg given 12 hours apart in patients 6 years of age and older.
- The tablets can be swallowed whole or divided in half and taken with water, or crushed and administered with applesauce. Each dose should be taken with food.
The efficacy of Egaten was demonstrated in an open label, randomized trial in Vietnam that compared the approved recommended dosage of triclabendazole to oral artesunate (4 mg/kg once daily for 10 days) in 100 patients (9 to 74 years of age) with acute symptomatic fascioliasis. After three months, 92% of the triclabendazole patients and 76% of the artesunate patients reported no clinical symptoms.
Additionally, six non-randomized, open label studies were conducted in Cuba, Bolivia, Peru, Chile, and Iran in a total of 245 adult and pediatric patients with stool-confirmed fascioliasis. Across these studies, there was found to be a dose response relationship, with the recommended two doses of 10 mg/kg of triclabendazole achieving a cure rate of 95.5% after 60 days.
Egaten should not be taken by patients with a known hypersensitivity to triclabendazole, other benzimidazole derivatives, or any of the other tablet ingredients.
Warnings and Precautions
Egaten may prolong the QT interval. Patients with a history of QT prolongation, or who are taking medications which prolong the QT interval should be ECG monitored.
The most common adverse reactions were abdominal pain, hyperhidrosis, nausea, decreased appetite, headache, urticaria, diarrhea, vomiting, musculoskeletal chest pain, and pruritus.
Development Timeline for Egaten
|Feb 13, 2019||Approval FDA Approves Egaten (triclabendazole) for the Treatment of Fascioliasis, a Neglected Tropical Disease|
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