COVID-19 Treatment: Remdesivir Gets Emergency Approval from FDA
CEO of Gilead Sciences Daniel O'Day met with U.S. President Donald Trump and announced the news along with FDA Commissioner Stephen Hahn, who regarded remdesivir as a crucial clinical advancement.
"It is the first authorized therapy for COVID-19," Hahn said, acknowledging the emergency powers at hand. He thanked the team and Trump for the drug.
First Authorized Therapy
Clinical tests using remdesivir have shown it is effective in aiding patients for recovery and prevents them from going into intensive care, these trials gave no clear and consistent indication if remdesivir can prevent deaths from the disease.
The situation is promising, Trump said. He continued by saying the administration was working with the FDA, the National Institutes of Health, and Gilead to make this happen as soon as possible.
Data from the most recent clinical test by NIH showed that patients sick with COVID-19 who were administered remdesivir recovered faster than patients who were given a placebo.
"I think this really illustrates what can happen in such a short time," Dr. Deborah Birx said.
As the official Coronavirus Task Force Coordinator at the White House, she deemed the development a step forward for the United States in combatting the pandemic with a therapeutic in less than 90 days.
Early March, Trump sat down with Daniel O'Day in a discussion about what the administration would be able to do to accelerate mass testing and production of therapeutics. The vaccines would be developed at 2021 soonest, medical experts predicted.
"The whole thing with therapeutics, to me, is very exciting," Trump said that day. "Especially when you're so far advanced."
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A Great First Step
After a federal trial that showed adequate improvements in ill patients, the FDA decided to approve remdesivir under emergency use provisions.
The clinical test was funded by the National Institute of Allergy and Infectious Diseases, and the results showed that the patients who were given remdesivir recovered faster than those who were given a placebo, 11 days, and 15 days respectively.
However, it can only treat so much, as it did not appear to reduce fatality rates among patients.
Director of the organization, Dr. Anthony S. Fauci, gave his input on the matter, saying the data was proof enough, but not a "knockout," or anything sensational for the media to bank on.
The chairman of the department of medicine at the University of Massachusetts Medical School agreed, calling the approval of the FDA to use remdesivir a "great first step."
Currently, remdesivir is approved for terminally ill patients who are at high risk. Formal approval is also waiting to be granted. Health workers like doctors and nurses in intensive care units consider the drug as hope for the pandemic to end-if not now, then eventually.
The Gilead team already made progress in the development of remdesivir in two months. Within the next few weeks, it is expected to be able to reduce the fatality rate with more tests.
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