Gilead Sciences Inc. said it is donating its existing supply of 1.5 million individual doses of remdesivir, its investigational medicine for coronavirus or Covid-19. The drug, which is yet to get regulatory approval, is available for compassionate use, expanded access and clinical trials to treat patients with the most severe symptoms of COVID-19.
It will be donated for broader distribution following any potential future regulatory authorizations. The company said its current supply of 1.5 million individual doses equate to well over 140,000 treatment courses for patients. These doses can be given through daily intravenous infusions in a hospital setting.
Over the next weeks and months, the company plans to increase supplies of remdesivir as raw materials with long lead times become available for manufacture. Gilead aims to produce more than 500,000 treatment courses by October and more than 1 million treatment courses by the end of this year.
Remdesivir is still an investigational medicine and has not been approved by any regulatory authorities in the world, and its safety and efficacy are not yet known.
It is the first compound to have entered into clinical testing in the U.S. The trial, sponsored by the National Institutes of Health, was initiated as recently as February 25, 2020. Multiple clinical trials for remdesivir are underway at present, involving thousands of patients with COVID-19 across the world.
In a statement, Chairman & CEO Daniel O’Day said the company has been consulting with regulatory authorities to establish additional expanded access programs for remdesivir. These programs would enable hospitals or physicians to apply for emergency use of remdesivir for multiple severely ill patients at a time.
In addition to the expanded access programs, the company continues to provide remdesivir on an individual compassionate use basis for children and pregnant women.
Gilead added that it is making progress in Europe. The European Medicines Agency announced that it has provided EU member states with recommendations on implementing expanded access programs for remdesivir in their countries.
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