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In the face of an emergency situation due to the covid-19 pandemic, the United States pharmaceutical market regulator, the Food and Drug Administration (FDA), plans to authorize the use of remdesivir for the treatment of patients infected with the new coronavirus , after a clinical trial showing that people taking this drug took less time to recover from the disease.
The news is advanced by the newspaper New York Times, which he reveals, citing an official US government source. The FDA will announce the granting of authorization for the use of remdesivir, an experimental drug developed to combat Ebola, which is being tested in the treatment of patients with covid-19, the disease caused by the new coronavirus. .
The newspaper explains that the granting of an “emergency authorization” by the FDA (as expected) does not correspond to the formal approval of a drug by the US agency. This is because when the federal government declares a public health emergency, the FDA can approve certain medications or tests to respond to the emergency if there are no other alternatives. This is the case in the current covid-19 pandemic, as no drug or vaccine has yet been shown to be effective against the new coronavirus. Therefore, remdesivir may become the first approved treatment for covid-19.
This Wednesday, President Donald Trump and Anthony S. Fauci, a respected immunologist and director of the National Institute of Allergy and Infectious Diseases (INAD), revealed that the initial results of a clinical trial with remive showed a “significant and positive” impact by decreasing the recovery time of patients with covid-19.
The large-scale study involved 1,063 covid-19 patients worldwide, according to INAD. On average, the group that was treated with remive he was discharged in 11 days. In the group taking the placebo medication, patients were discharged from the hospital on average in 15 days.
During a White House press conference, Anthony S. Fauci warned that the study has not yet been reviewed by his peers, but revealed that the results are promising and that the drug has been shown to have “a clear, significant and positive effect on decreasing time. ” recovery. “Anthony Fauci even noted that the results” were so promising “that, in this case, there is” an ethical obligation to inform the placebo group immediately so that they can have access “to the medication.
According to Anthony S. Fauci, the results showed that the drug remdesivir could decrease the recovery period from the disease by about a third. “Although an improvement of 31% does not seem to be a surprising 100%, it corresponds to a very important validation of the concept because what it showed was that a medicine can block the virus“Fauci said, showing himself “Very optimist”.
Donald Trump also found the study results to be promising. “It is certainly a very positive event,” he said. As early as Wednesday afternoon, during a meeting at the White House, the President of the United States said he wanted The FDA acts “as soon as possible” Regarding the possible approval of remdesivir for the treatment of covid-19, reveals the Reuters agency. Emphasizing the importance of safety in these types of procedures, Trump said, on the other hand, that he would like to see approvals given “very quickly,” especially with respect to “working” drugs.
Contradictory results?
Another study, conducted in ten hospitals in Hubei, China, and published this Wednesday in the scientific journal. Lancet, questions the efficacy of the drug in the treatment of seriously ill patients with covid-19, however, leaving open the possibility that the remediation may be effective in other cases.
Between February 6 and March 12, 2020, 237 patients participated in this study, who were randomly included in the two treatment groups: 158 to be treated with remdesivir and 79 who received the placebo. The authors of the article concluded that “the use of remdesivir was not associated with a difference in time of clinical improvement.” “In this study of adult hospitalized patients with severe covid-19, remdesivir was not associated with statistically significant clinical benefits. However, the numerical reduction in time of clinical improvement in those [doentes] those who underwent treatment before require confirmation in larger studies, “they add. However, according to the New York Times, the sample of patients who participated in this study was not sufficient.
Vials with the drug remdesivir in a laboratory of Gilead Sciences, California (USA)
Gilead Sciences Inc / REUTERS
“Unfortunately, our study revealed that while safe and well tolerated, remdesivir did not provide significant benefits beyond placebo,” he told the New York Times Bin Cao, lead author of the study. “This is not the result we expected,” he concluded.
“Positive data”, but caution is needed
The North American biopharmacology company Gilead Sciences, which developed remdesivir, said in a statement that it was “aware of the positive data that emerged” from the (initially reported) clinical trial supervised by INAD. “We understand that the study has achieved its main objective and that INAD will provide detailed information at an upcoming press conference,” he said.
The company recalls, however, that remdesivir is not yet licensed or approved in the United States or in any other country “and has not yet been shown to be safe or effective for any use, including treatment with covid-19.”
“As we have done since the start of the pandemic, we have been sharing information, transparently and as it becomes available, with the Administration, other agents and the public,” added a representative from Gilead Sciences in an email sent Wednesday. . just for New York Times.
Company spokesman Ryan McKeel said Gilead Sciences cannot speculate on the next actions the federal government will take. “However, we continue to discuss with them the growing body of evidence for the [uso do] remdesivir as a potential treatment for covid-19, with the aim of making remdesivir more complete and available to patients who urgently need treatment, “he added, quoted by the same newspaper.
The New York Times He states that some reports were published, namely, in prestigious publications such as the magazine New England Journal of Medicine, who reported on patients who reportedly recovered after taking remedies, although the results were in fact uncertain, undermining the confidence and credibility of studies on this drug.
However, it is essential that studies compare the effects of the drug. remive and a placebo in the patients, to find out if the patients improved due to the effect of the medicine or only with the help of basic medical care.
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