The National Health Surveillance Agency (Anvisa) approved, this Wednesday (30), the temporary authorization for emergency use, on an experimental basis, of the drug Paxlovid (nirmatrelvir + ritonavir) for the treatment of Covid-19. The decision of the agency’s Collegiate Board takes place after a public meeting.
The drug is made up of nirmatrelvir and ritonavir tablets that are packaged and given together. The indication for use is aimed at the treatment of Covid-19 in adults who do not require supplemental oxygen and who are at increased risk of worsening the disease.
The drug already has approval for emergency use in the United States by the Food and Drug Administration (FDA); in Europe by the European Medicines Agency (EMA), in Canada, China, Australia, Japan, the United Kingdom and Mexico.
The request for emergency use was received by Anvisa on February 15th via Wyeth Indústria Farmacêutica Ltda./Pfizer.
At the meeting, director Meiruze Freitas, rapporteur of the process, said that all available scientific evidence was evaluated and that the decision for approval took into account the balance between risks and benefits, known or potential, of the drug.
“All cases of medicines and vaccines against Covid-19 submitted to the agency were exhaustively evaluated by a multidisciplinary team of public servants who committed all their efforts so that, in Brazil, access to different vaccines and treatments was given”, he said.
Source: CNN Brasil