So far, Anvisa has authorized the emergency use of only three drugs against the disease; tests on the effectiveness of hydroxychloroquine are being carried out in the country
So far, the National Health Surveillance Agency (Anvisa) approved the emergency use of only three drugs against the Covid-19. On April 20, the agency authorized the use of the first association of antibodies against the disease: a cocktail of casirivimabe e imdevimabe, produced by pharmaceutical Roche. On May 13, Anvisa released a new combination composed by banlanivimabe e etesevimabe, substances produced in the laboratory that, when injected into the body, act like other antibodies present in the human body. The drug is produced by pharmaceutical company Eli Lilly do Brasil. In addition to the two cocktails, Anvisa also gave prior approval to the use of the antiviral Remdesivir. On July 19, the institution received the request for the emergency use of another drug, the Sotrovimabe, which is a monoclonal antibody. The study on the drug was carried out globally and recruited 1,062 participants, 22 people in Brazilian research centers. Documents on the use of Sotrovimabe are still being analyzed by the agency.
Drugs approved for treatment against Covid-19
- Remdesivir – It was the first drug approved by Anvisa for the treatment against Covid-19. Remdesivir is an antiviral that stops the coronavirus (Sars-Cov-2) from multiplying in cells. The use of the drug is indicated for adults and adolescents (aged 12 years or older and with a body weight of at least 40 kg) hospitalized with pneumonia who need extra oxygen to help them breathe, but who are not under artificial ventilation.
- Casirivimabe + Imdevimabe (Regn-CoV2) – It is a combination of two monoclonal antibodies that target the spicular protein S, which the coronavirus uses to bind to the human cell. the cThe cocktail can only be used in a hospital for the beginning of the diagnosis — when there is a tendency for a worsening of the clinical condition of the patient, over 12 years old, weighing at least 40 kg, and who does not need oxygen supplementation. Not for use in critically ill patients.
- Banlanivimabe + Elevel – Like Regn-CoV2, the cocktail is also a combination of two monoclonal antibodies that target the spike protein of the coronavirus. Use is restricted to hospitals. It is indicated for patients at high risk of progression from Covid-19. Not to be used in critically ill patients Where who require oxygen or mechanical ventilation in their treatments.
Is use of ‘Kit Covid’ recommended?
The drugs that make up the so-called ‘covid kit’, such as chloroquine, hydroxochloroquine, ivermectin and azithromycin, have not yet had their emergency use approved by Anvisa. THE National Commission for the Incorporation of Technologies (Conitec) no Health Unic System (SUS) even advised against the use of these drugs against the disease. “Some drugs have been tested and have not shown clinical benefits in the population of hospitalized patients, and should not be used, namely: hydroxychloroquine or chloroquine, azithromycin, lopinavir/ritonavir, colchicine and convalescent plasma. Ivermectin and the association of casirivimab + imdevimab have no evidence to justify their use in hospitalized patients, and should not be used in this population”, says the Conitec report on the “Brazilian Guidelines for Hospital Treatment of Patients with Covid-19”. Despite not having their use or proven efficacy, new studies are being carried out on hydroxychloroquine, chloroquine and azithromycin.
Medicines being studied in Brazil
- Hydroxychloroquine and azithromycin – Currently, hydroxychloroquine is used for the prevention and treatment of malaria and is not recommended against Covid-19. But, in June of this year, Anvisa authorized the Hospital Israelita Albert Einstein to carry out tests to verify the drug’s effectiveness against the disease caused by the coronavirus infection. The agency approved two studies of the drug. An open, controlled, on the use of hydroxychloroquine and azithromycin for prevention of complications in patients with virus infection and a survey to assess the safety and clinical efficacy of hydroxychloroquine associated with azithromycin in critically ill patients with pneumonia caused by the disease.
- Proxalutamide – The drug is an antiandrogen studied as a possible treatment for prostate and breast cancer. In July 2021, Anvisa authorized the business Suzhou Kintor Pharmaceuticals, headquartered in China, conducting tests on the effectiveness of the drug against Covid-19 in the country. The search will assess the safety and efficacy of the drug proxalutamide in the reduction of viral infection caused by the virus and in the inflammatory process caused by Covid-19. Will participate in the study 12 volunteers from the state of Roraima and another 38 from São Paulo.