Gilead rescinds FDA designation for potential coronavirus treatment
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Gilead Sciences on Wednesday asked the U.S. Food and Drug Administration to rescind the orphan status designation given to its drug remdesivir, an antiviral medicine that is being tested as a potential treatment for the coronavirus.
“Gilead has submitted a request to the U.S. Food and Drug Administration to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the treatment of COVID-19 and is waiving all benefits that accompany the designation,” the company said in a statement.
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Orphan status, which is intended to incentivize treatments for rare diseases affecting fewer than 200,000 people, was granted to Gilead on Monday.
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The designation sparked criticism because it is unlikely that coronavirus would fit the rare disease criteria in the United States.
The designation comes with a number of benefits, including a seven-year monopoly on sales. It would have control over pricing and there were concerns some individuals would not be able to afford it.
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Independent Vermont Sen. Bernie Sanders, who is seeking the Democratic nomination to run for president in November, accused the company of putting profits above human life.
Gilead said on Wednesday that it is confident it can maintain its accelerated timeline to meet regulatory review without the designation.