“When the news of the coronavirus first emerged, Gilead immediately began to investigate the potential of remdesivir, a medicine we had been studying for many years as part of our extensive research in antivirals. Remdesivir had never been approved for use but based on what we had learned to date, we knew it might have potential with the novel coronavirus. Since then, we have been working with the greatest sense of urgency and responsibility to determine whether remdesivir does indeed work against COVID-19,” he writes.
“Multiple studies are ongoing, and we are on track to have initial data in the coming weeks. If it is approved, we will work to ensure affordability and access so that remdesivir is available to patients with the greatest need.
“In the meantime, we have made the investigational medicine available for severely ill patients who cannot enroll in a trial. This ‘compassionate use’ program is typically reserved for a small number of individual cases but there is nothing typical about this crisis and to date we have provided remdesivir to more than 1,000 patients.
“With expanded access, hospitals or physicians can apply for emergency use of remdesivir for multiple severely ill patients at a time. While it will take some time to build a network of active sites, this approach will ultimately accelerate emergency access for more people.”
Last week, Gilead dropped its orphan drug designation for remdesivir, a status granted by the FDA that would have extended monopoly rights for the drug if it came on the market.
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