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Anvisa is in contact with Gilead, a company that manufactures remdesivir abroad, to follow the evolution of studies on the drug to treat covid-19, a disease caused by the new coronavirus (SARS-CoV-2).
The FDA (Food and Drug Administration) authorized the use of the drug in the United States on Friday (1) for the treatment of the disease in hospitalized patients in serious condition. “Based on all the available scientific evidence, it is reasonable to believe that remdesivir can be effective in the treatment of Covid-19 and that, when used under the conditions described in this authorization, the known and potential benefits outweigh the known risks and drug potentials. ” , indicates the document of the organ.
In the coming days, the Brazilian regulatory body should hold a meeting with the manufacturer to verify the interest and feasibility of supplying the drug in Brazil.
Gilead has several clinical trials underway to remdesivir, and initial data is expected to be released in the coming weeks. If the benefit of the medication is proven, Anvisa has mechanisms, such as consent for its use in a healthcare program and prioritization of registration, to ensure rapid access to the population for the medication.
At the moment, remdesivir does not have a request for registration in the country, nor a request for consent in clinical research with the drug. Unlike academic or scientific research, clinical research is intended to support registration or alteration of registration, such as the inclusion of a new therapeutic indication on package inserts, for example.
The studies presented are contradictory.
The authorization of remdesivir was already expected after the publication of modestly positive results of the use of the drug against the new coronavirus.
The data comes from a survey conducted by the American National Institute of Health (NIH), which analyzed 1,063 patients in the United States, Europe, and Asia. Patients were divided into those who received a placebo treatment and those who took remdesivir, an antiviral used to treat Ebola.
Preliminary analysis of the study indicates that patients treated with the drug recovered approximately four days earlier than the others. The death rate among those who used the drug would also be lower.
But scientists around the world remain skeptical about the news, as in another recent study by Chinese doctors and published by the magazine. The lancet, the antiviral had little result among the tested patients.
Who is right?
Developed to fight Ebola, remdesivir had already had good results when used to treat patients suffering from coronaviruses that cause SARS and MERS. However, studies with SARS in 2002 showed that the longer it took to use remdesivir, the less effective it was.
This could explain why the patients in the Chinese study did not have any beneficial effect with the administration of the drug, since they were in a serious condition of covid-19.
After that, scientists await the results of other large-scale tests conducted with the drug to draw their conclusions. One of them is the Discovery clinical study, carried out by the French research institute Inserm since March 24 and which also takes into account thousands of people.
* with information from Ascom / Anvisa and RFI.
