US approves use of experimental drug remdesivir for covid-19 patients | Society

The United States Food and Drug Administration (FDA) has authorized the emergency use, for the treatment of patients of covid-19, of the experimental antiviral remdesivir, one of the most promising drugs in the fight against the disease caused by the coronavirus. “Having concluded that the criteria for approval of this authorization have been met, I authorize the emergency use of remdesivir for the treatment of covid-19,” explains Denise M. Hinton, chief scientist at the FDA, in a letter dated this May 1, addressed to the American pharmaceutical company Gilead, manufacturer of the remdesivir. President Donald Trump had advanced the news the same Friday afternoon, in an appearance in the Oval Office together with Daniel O’Day, CEO of Gilead. The government says it is working to make the drug available to patients as soon as possible, and the company has announced that it will donate a million doses of the drug.

“We want to thank the collaboration that has led to remdesivir up to this point and the many people who have been part of this,” Trump said, according to CNBC. “It is really a very promising situation.”

What the FDA has done is not a formal approval of the drug. But the declaration of a public health emergency by the federal government allows it to authorize the use of certain medications to combat the emergency in the absence of other alternatives, even when complete data on their efficacy and safety do not exist. Thus, remdesivir becomes the first approved treatment for covid-19.

The drug yielded positive results in a federal clinical trial, which has shown that treatment with remdesivir can accelerate recovery for covid-19 patients. The trial was conducted with 1,063 critically ill patients, some of whom were given remdesivir while others received placebo. Those treated with remdesivir took an average of 11 days to heal while those treated with placebo took an average of 15 days. The trial did not show a significant reduction, however, in the patient mortality rate. “It has been shown that it is a medicine that can block the virus,” said epidemiologist Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, on Wednesday. “This will be the standard of treatment.”

The study, conducted by the National Institute of Infectious Diseases (NIAID), a branch of the National Institutes of Health (NIH), has not been reviewed by independent experts or published in a scientific journal. It is very unusual for the results of a clinical trial to be made public without going through the review process, and many doctors ask for caution.

Developed to treat Ebola but not proven to be effective, remdesivir is one of the most promising drugs to become the standard treatment for covid. The drug detects the viral genome and blocks the RNA polymerase protein (RdRp), which multiplies copies of the virus. Without this protein, the disease-causing coronavirus covid-19 cannot replicate and the infection is blocked.

Given the complexity of having a vaccine that against the pathogen, the focus has been on possible treatments, and that attention has caused, on occasions, to dispense with the scientific method in the marketing of drugs. On Wednesday, the same day that NIAID released its preliminary study results, Gilead released the first data from one of its own clinical trial, which it called “promising.” Despite the limitations of the study, which was neither done in a control group nor has it been peer-reviewed, the Gilead announcement caused spikes in the bags. Soon after, the prestigious medical journal The Lancet The first clinical trial on remdesivir with a control group and reviewed by independent experts was published by surprise, and the results show that the drug does not provide significant advantages to covid patients.

On Thursday, Gilead announced that it expects to produce more than 140,000 doses of its ten-day remdesivir treatment by the end of May, and that it will be able to produce a million of them by the end of the year.

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