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WASHINGTON: The US Food and Drug Regulatory Agency. USA It has allowed the emergency use of an investigational antiviral vaccine to treat patients with Covid-19 after some research, including one led by an American Indian doctor, found that the drug helped recover part of the vaccine from infected cases faster. .
The Food and Drug Administration (FDA) authorized the Emergency Use (USA) for investigational use of Remdesivir antiviral in the treatment of patients with Covid-19.
The FDA clearance came after investigations, including one led by American Indian physician Aruna Subramanian, reported that Remdesivir shortened recovery times in people who became ill from the new coronavirus.
“I am pleased to announce that Gilead now has an FDA USA (Emergency Use Authorization) for Remdesivir,” United States President Donald Trump told reporters at the White House on Friday.
Trump said the United States is an important treatment for hospitalized patients with coronavirus.
Health and Human Services Secretary Alex Azar said this is a significant step in the fight against Covid-19.
The EUA allows Remdesivir to be distributed in the US. USA And be administered intravenously by healthcare providers, as appropriate, to treat suspected or laboratory-confirmed Covid-19 in hospitalized adults and children with serious conditions.
By Friday, more than 63,000 Americans have died from the coronavirus and more than a million have tested positive for Covid-19.
Trump said his administration has been working with teams from the FDA, the National Institute of Health and Gilead to spearhead this public-private partnership to make this happen very quickly.
“I think this really illustrates what can happen in such a short time. For the first case, which was diagnosed in the United States so far, our first step forward with a therapeutic in less than 90 days,” said Deborah Birx, a member of the White House Task Force on Coronavirus.
In a statement, Gilead said the EUA will facilitate broader use of Remdesivir to treat hospitalized patients with severe Covid-19 disease, allowing access to the vaccine in additional hospitals across the country.
Remdesivir is licensed for the treatment of hospitalized patients with severe Covid-19 disease, he said, adding that the optimal duration of treatment is still being studied in ongoing clinical trials.
Under the US, treatment durations of five days and 10 days are suggested, depending on the severity of the disease. The authorization is temporary and does not replace the formal process for submitting, reviewing and approving new drug applications, Gilead said.
“This USA opens the way for us to provide emergency use of Remdesivir to more patients with severe symptoms of Covid-19,” said Daniel O’Day, president and CEO of Gilead Sciences.
“We will continue to work with partners around the world to increase our supply of Remdesivir as we move forward in our ongoing clinical trials to complement our understanding of the drug’s profile. We are working to meet the needs of patients, their families, and healthcare workers in everyone with the greatest sense of urgency and responsibility, “he said.
According to Gilead, the EUA is based on available data from two global clinical trials: the National Institute of Allergy and Infectious Diseases phase 3 placebo-controlled study in patients with moderate to severe symptoms of Covid-19, including those who were severely sick. and the global Gilead Phase 3 study evaluating the 5-day and 10-day dosing durations of Remdesivir in patients with severe disease.
Multiple additional clinical trials are underway to generate more data on the vaccine’s safety and efficacy as a treatment for Covid-19, he said.
Subramanian, MD, chief clinical medicine professor, Immunocompromised Host Infectious Diseases, Stanford University School of Medicine, is one of the study’s principal investigators.
Previously, in an interview for Fox News, Subramanian said, “There is much more work to be done in terms of exactly who should receive this medication, what is the best time, who is at the highest risk for complications. And what can we add to this or what can we improve to further improve the results “.
“This (remdesivir) is a direct acting antiviral. It has been shown to be very promising in the laboratory and in animal models and, for the first time, now in human clinical trials,” Subramanian told Fox News.
“We know that so far, it has been very safe and tolerable. We have had good clinical results and yesterday we found that, compared to placebo, that is, people who do not receive drugs, people do much better,” he said.
FDA Commissioner Stephen M. Hahn said: “Today’s action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients with timely access to new therapies when appropriate, while simultaneously support research to assess whether they are safe and effective. ”
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The Food and Drug Administration (FDA) authorized the Emergency Use (USA) for investigational use of Remdesivir antiviral in the treatment of patients with Covid-19.
The FDA clearance came after investigations, including one led by American Indian physician Aruna Subramanian, reported that Remdesivir shortened recovery times in people who became ill from the new coronavirus.
“I am pleased to announce that Gilead now has an FDA USA (Emergency Use Authorization) for Remdesivir,” United States President Donald Trump told reporters at the White House on Friday.
Trump said the United States is an important treatment for hospitalized patients with coronavirus.
Health and Human Services Secretary Alex Azar said this is a significant step in the fight against Covid-19.
The EUA allows Remdesivir to be distributed in the US. USA And be administered intravenously by healthcare providers, as appropriate, to treat suspected or laboratory-confirmed Covid-19 in hospitalized adults and children with serious conditions.
By Friday, more than 63,000 Americans have died from the coronavirus and more than a million have tested positive for Covid-19.
Trump said his administration has been working with teams from the FDA, the National Institute of Health and Gilead to spearhead this public-private partnership to make this happen very quickly.
“I think this really illustrates what can happen in such a short time. For the first case, which was diagnosed in the United States so far, our first step forward with a therapeutic in less than 90 days,” said Deborah Birx, a member of the White House Task Force on Coronavirus.
In a statement, Gilead said the EUA will facilitate broader use of Remdesivir to treat hospitalized patients with severe Covid-19 disease, allowing access to the vaccine in additional hospitals across the country.
Remdesivir is licensed for the treatment of hospitalized patients with severe Covid-19 disease, he said, adding that the optimal duration of treatment is still being studied in ongoing clinical trials.
Under the US, treatment durations of five days and 10 days are suggested, depending on the severity of the disease. The authorization is temporary and does not replace the formal process for submitting, reviewing and approving new drug applications, Gilead said.
“This USA opens the way for us to provide emergency use of Remdesivir to more patients with severe symptoms of Covid-19,” said Daniel O’Day, president and CEO of Gilead Sciences.
“We will continue to work with partners around the world to increase our supply of Remdesivir as we move forward in our ongoing clinical trials to complement our understanding of the drug’s profile. We are working to meet the needs of patients, their families, and healthcare workers in everyone with the greatest sense of urgency and responsibility, “he said.
According to Gilead, the EUA is based on available data from two global clinical trials: the National Institute of Allergy and Infectious Diseases phase 3 placebo-controlled study in patients with moderate to severe symptoms of Covid-19, including those who were severely sick. and the global Gilead Phase 3 study evaluating the 5-day and 10-day dosing durations of Remdesivir in patients with severe disease.
Multiple additional clinical trials are underway to generate more data on the vaccine’s safety and efficacy as a treatment for Covid-19, he said.
Subramanian, MD, chief clinical medicine professor, Immunocompromised Host Infectious Diseases, Stanford University School of Medicine, is one of the study’s principal investigators.
Previously, in an interview for Fox News, Subramanian said, “There is much more work to be done in terms of exactly who should receive this medication, what is the best time, who is at the highest risk for complications. And what can we add to this or what can we improve to further improve the results “.
“This (remdesivir) is a direct acting antiviral. It has been shown to be very promising in the laboratory and in animal models and, for the first time, now in human clinical trials,” Subramanian told Fox News.
“We know that so far, it has been very safe and tolerable. We have had good clinical results and yesterday we found that, compared to placebo, that is, people who do not receive drugs, people do much better,” he said.
FDA Commissioner Stephen M. Hahn said: “Today’s action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients with timely access to new therapies when appropriate, while simultaneously support research to assess whether they are safe and effective. ”
