Gilead Sciences Inc's GILD remdesivir has been granted U.S. Food and Drug Administration emergency use for the treatment of the coronavirus (COVID-19).
Vice President Mike Pence announced 1 million vials of remdesivir will be distributed to hospitals on Monday.
The FDA Emergency use authorization letter states:
The emergency use of remdesivir for the treatment of COVID-19 when administered as described in the Scope of Authorization (section II) meet the criteria for issuance of an authorization under Section 564(c) of the Act, because:
1. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus;
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of remdesivir when used to treat COVID-19 outweigh the known and potential risks of such products; and
3. There is no adequate, approved, and available alternative to the emergency use of remdesivir for the treatment of COVID-19.3
President Donald Trump announced the news Friday afternoon alongside Gilead CEO Daniel O’Day.
“We want to thank the collaborators that brought remdesivir to this point and many of our people that have been part of this, in fact, the caregivers,” O’Day said.
Gilead's stock closed Friday's session down 4.8% at $79.95 per share. The stock has a 52-week high of $85.97 and a 52-week low of $60.89.
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