Remdesivir is approved by Anvisa to treat Covid-19; know the details
Remdesivir is approved by Anvisa to treat Covid-19; know the details
The first antiviral to be recommended for patients with Covid-19 in the package insert is remdesivir, approved this Friday (12th) by the National Health Surveillance Agency (Anvisa). The agency also granted definitive registration for Covishield, the vaccine developed by AstraZeneca in partnership with the University of Oxford, in the United Kingdom. With this release, the immunizer can be used in the general population.
According to Raphael Sanches Pereira, specialist in the quality management of medicines at Anvisa, the application for approval of remdesivir was submitted to the agency on August 6, 2020. “After that, we had some conversations to better understand because it is a drug developed with great speed. and many aspects are not yet closed ”, he explains.
The formula will have the trade name of Veklury and will be sold in the form of “powder for solution for injection” that must be reconstituted at the time of application. It can only be used in hospitals and offered to patients over 12 years old and at least 40 kg.
Antiviral remdesivir. Photo: Taj Pharma/https://tajpharma.in/contact/
Patients who have pneumonia and need oxygen supplementation can receive it, since the therapeutic indication approved in the package insert is linked to the presentation of pneumonia. The antiviral should be used for a minimum of five days and a maximum of ten days.
Brazil is not the first country to approve the drug for the treatment of Covid-19. Entities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are among them. Renata Lima Soares, Anvisa's Safety and Efficacy Assessment manager, says the antiviral can prevent the progression of the infection and shorten the recovery time.
Despite all of Anvisa's defense of the drug, a study of the World Health Organization (WHO) does not recommend its use in hospitalized Covid-19 patients, regardless of severity. According to entity, antiviral does not prevent deaths or worsening of the disease. The studies evaluated by WHO totaled more than 7 thousand patients evaluated at the time.
Gustavo Mendes, general manager of Medicines and Biological Products at Anvisa, explains that the WHO assessed the mortality profile, which is different from that analyzed by the agency. “We considered it to be another therapy to combat Covid-19. WHO's focus was on preventing deaths. The studies that we consider valid are about reducing the length of hospital stay for patients. ”
Mendes points out that the data examined by the agency indicate that the average length of stay for patients with oxygen support treated with remdesivir has decreased from 15 to 10 days compared to those who have not received the antiviral. In addition, Anvisa informs that there are no other requests for registration of drugs for the treatment of patients with Covid-19.
How does remdesivir work?
O remive is a synthetic intravenous drug. When applied in the patient's vein, always in a hospital environment, it supposedly prevents viral replication. In addition to its effectiveness not being clinically proven against the disease, it is not yet known what its possible side effects are.
And the cost of the antiviral is quite high: a five-day treatment (minimum recommended time) has an average cost of US $ 3.120, according to the pharmaceutical Gilead Sciences, who developed the formula. This means something like R $ 17,3 thousand (at the exchange rate this Friday). For now, there is no information on the price of the product in Brazil.
The antiviral is already in emergency use in the USA. When it was created, it was intended for the treatment of hepatitis, against which it did not work. Afterwards, it was tested against Ebola, but it also did not have good results.
It must be kept in mind that remdesivir is not indicated for mild cases, asymptomatic patients or as early treatment. It is specific for pneumonia patients who need oxygen supplementation without intubation. In other words, antiviral does not replace vacina nor the disease prevention measures, which include the wearing masks, social distance and hand hygiene.
Street: CNN
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