The U.S. Food and Drug Administration on Monday granted an orphan drug designation to Gilead Sciences’ Remdesivir, an experimental drug touted by the Trump administration as a potential treatment for the coronavirus outbreak.
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Remdesivir is an antiviral drug that was once tested as a potential treatment for Ebola. Multiple clinical trials are underway to assess Remdesivir’s viability as a safe, effective treatment to combat coronavirus.
Orphan status is reserved for drugs that treat conditions that are thought to have limited potential for profitability without government sponsorship or assistance. Companies that sponsor a drug eligible for orphan status gain access to incentives designed to aid development, such as tax credits for clinical testing and a seven-year exclusivity window on production.
Gilead Sciences did not immediately respond to a request for comment. Company shares rose as much as two percent in after-hours trading.
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There were more than 370,000 individual confirmed cases of coronavirus as of Monday, according to a Johns Hopkins University database. U.S. authorities have reported more than 41,700 cases and 573 deaths.
Speaking at a White House coronavirus briefing last week, President Trump touted Remdesivir as one of several promising treatments for COVID-19, the illness caused by coronavirus. At present, there is no known cure for the disease, although medical experts around the world are working to find a vaccine.
"It could have a very positive effect, or a positive effect, maybe not very, but maybe positive," Trump said regarding the potential treatments. "It’s very, very exciting."
FDA officials granted the orphan designation one day after Gilead Sciences suspended an emergency access program for the drug amid surging demand.
“We recognize that there are severely ill patients who are unable to enroll in clinical trials and for whom no approved treatment options are effective,” the company said in a statement. “Gilead has been working with regulatory agencies to provide Remdesivir to these patients where feasible.”