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news.US-based drug development firm MediVector has completed enrollment in two Phase III FAVOR trials of favipiravir, an orally administered novel anti-viral compound, in adults with uncomplicated influenza (flu).
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A total of 2,021 patients were enrolled in the both the randomized, double-blind, placebo-controlled, multi-centered trials at participating clinics and practices in the Americas, Europe, Australia, New Zealand and South Africa.
The company said that favipiravir has a unique mechanism of action that is active against a wide range of RNA-based viruses in laboratory tests.
MediVector executive vice-president and chief medical officer Dr Carol Epstein said: "Completion of enrollment within a year of initiating these clinical trials is a significant accomplishment, and the resulting data from the carefully designed studies will lay the groundwork for filing an application for approval to market favipiravir in the US.
"Resistance to currently available influenza treatments is a growing problem, and there is an urgent need for a new broad-spectrum therapeutic with a different mechanism of action that is active against multiple strains of influenza viruses."
The two trails are evaluating the time to alleviation of all primary influenza symptoms consistent with uncomplicated influenza, after treatment with favipiravir.
Currently, data review is being carried out and following its completion the trial reports will be provided to the FDA.
Development of favipiravir is being carried out by the Department of Defense’s BioDefense Therapeutics (BDTX), a Joint Product Manager within the Medical Countermeasure Systems (JPM-MCS) Joint Project Management Office.