FDA Gives Emergency Approval for COVID-19 Treatment Drug
FDA Approves new drug called remdesivir
The U.S. Food and Drug Administration has issued an emergency use authorization for an investigational antiviral drug called remdesivir to treat a number of adults and children confirmed infected with COVID-19, according to the department's website. The drug is to be administered once per day for up to 10 days, and is believed to hasten patients' recovery, reports HuffPost.
U.S. President Trump told reporters about the announcement at the White House on Friday.
Daniel O'Day, CEO of Gilead, said remdesivir maker Gilead Sciences will donate 1.5 million vials of the drug and will work with the federal government to quickly distribute it to patients in need, according to NPR.
This comes days after early results from a study of the drug revealed it may help patients recover more quickly. Director of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci has since hailed the findings from earlier this week as "quite good news."
UPDATE May 1, 5:40 PM EDT: Fauci on Remdesivir, and the drug's study results
"The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recover," said Fauci at the White House on Wednesday.
The earlier study strengthening the case for remdesivir's effects was randomized and controlled, with results released the same day. Since late February, 1,063 patients suffering from advanced COVID-19 in 22 nations were given either the remdesivir drug, or a placebo. Patients receiving placebo recovered after an average of 15 days, while the group given the drug itself made a full recovery in 11 days on average — an incredible 31% difference.
Notably, the mortality rate for the remdesivir-receiving group was also lower than for the placebo group.
However, the study — completed earlier this week — still requires peer review, and shows data that differs from other studies that showed disappointing results with remdesivir, which would mean the drug isn't as helpful as it seems, reports HuffPost.
"This is really quite important for a number of reasons," said Fauci. "Although a 31% improvement doesn't seem like a knockout, 100%, it is a very important proof of concept. What it has proven is that a drug can beat this virus."
UPDATE May 1, 6:00 PM EDT: Fauci compares remdesivir to early HIV drug AZT
To drive his point home, Fauci referenced the medical community's response to the AIDS crisis. The first HIV treatment drug AZT showed "modest" results in its early trials, but subsequent research and testing created a much more potent and effective drug, said Fauci.
O'Day reiterated Fauci's AIDS comparative statement on Friday, and said that although "we're still early days on the coronavirus, this is the first step today." O'Day added that remdesivir's manufacturing time has been reduced from 12 months to only six months.
Fauci illustrated how the drug works, saying it blocks "an enzyme that the virus uses."
An FDA information sheet for COVID-19 patients and families states that remdesivir hasn't completed the full FDA review. It stresses that this was an emergency use authorization, given only when there are no alternatives and scientific methods show "it is reasonable to believe that this product meets certain criteria for safety," reads the sheet.
Gilead is only one of several companies in a wild rush to seek out a cure for the virus that swept the world and crashed the economy and, as of writing, killed more Americans than the Vietnam War. Other drugs are also under development.
Toward the procurement of new COVID-19 treatments, researchers will try combining the other drugs with remdesivir, to look for a stronger concoction.
After reviewing EUA criteria & the science, we determined it reasonable that remdesivir may be effective in treating #COVID19, & that, given a lack of adequate, approved, or available alternative treatments, the known & potential benefits outweigh the known & potential risks.— Dr. Stephen M. Hahn (@SteveFDA) May 1, 2020
Stephen Hahn, FDA Commissioner, said that the agency is working "around the clock" to hasten efforts in search of effective COVID-19 treatments.
A viable vaccine, however, is not expected until at least next year.
This is breaking news, so be sure to return for the latest developments.
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