The Food and Drug Administration approved the emergency use of the experimental antiviral drug remdesivir to treat COVID-19.
Emergency clearance is not only FDA-approved as a standard after a detailed review showing that the drug can safely and effectively treat a particular disease. The agency can issue an Emergency Use Authorization (EUA) for unapproved medical products that can help treat life-threatening illnesses in the absence of unapproved alternative medicines, and that's it.
We need final data from clinical trials included in the FDA application to determine if remdesivir is safe and effective for treatment or prevention Corona virus infection -19: Corona 19.
— Dr. Janet Woodcock (@DrWoodcockFDA) May 1, 2020
This approval does not prove that the drug works in FDA's general benchmarks, but according to the agency's letter of approval, “The known and potential benefits of remdesivir when used to treat COVID-19 are the known risks and potential of such products. It is greater than the risk. ”
With permission, the drug can be used to treat patients who are hospitalized with severe enough disease that need to receive supplemental oxygen or be placed in a ventilator.
The pharmaceutical company Gilead, which makes Remdesivir, has previously announced it plans to abandon all existing drug supplies to treat more than 140,000 patients. Gilead said in a press release that the U.S. government is responsible for distributing Les Messivir to hospitals, but it is still unclear when the company will release the drug under a new permit.
Research showing that remdesivir blocks the activity of new coronaviruses in cells has made it a major candidate for treatment. Gilead originally developed an ebola remedy. Prior to this approval, physicians were able to treat COVID-19 patients with remedyvir by enrolling in clinical trials or making individual requests to pharmaceutical companies in accordance with FDA's gracious use policy.
The drug's clinical trial data was mixed. In a study this week, the National Institute of Allergy and Infectious Diseases (NIAID) revealed that patients treated with remedyvir recovered from COVID-19 four days earlier than patients receiving placebo. Compared to 11% of the placebo group, 8% of the groups receiving the drug died. The NIAID later revealed that it would release more detailed data for this study involving more than 1,000 patients, and it is difficult to critically analyze the results at this point.
Anthony Fauci, head of NIAID, called the result "good news." He said at the White House this week that "the drug has been proven to block this virus." Former FDA Commissioner Scott Gottlieb got more reservations about the results. "It's evolutionary, not revolutionary," he tweeted.
Concise Aritaum. Evolutionary, not revolutionary. Remdesivir appears to be active and may help some patients. start. You need better medicine and ultimately a vaccine. However, when used properly, it can help, especially if you have antibody medications until fall. https://t.co/gUt7M6AGpt
— Scott Gottlieb, MD (@ScottGottliebMD) April 29, 2020
But on the same day, a study in China found that patients who took the drug no It improves faster than patients treated with placebo. “Unfortunately, our experiments are safe and endurable, but we found that remdesivir does not offer a significant advantage over placebo,” said Bin Cao of the researcher's chief investigator China-Japan Friendship Hospital and Beijing Capital Medical University. New York Times.
Drug testing is difficult under normal circumstances and more difficult during pandemic pandemics. This new corona virus kills thousands of people every day, and people around the world have to put tremendous pressure on new data and inflate positive signals to find the answer. There are no drugs that have been proven to be safe and effective treatments for COVID-19, and research into medèvir and other therapeutic candidates continues.