The National Health Surveillance Agency (Anvisa) approved this Wednesday (30) the authorization, on an emergency basis, of the drug for covid-19 Paxlovid, which comprises the combined use of the drugs nirmatrelvir and ritonavir. The product is manufactured by Wyeth Pharmaceuticals.
The drug is indicated for adults who have tested positive, who do not need oxygen and who are at risk of developing severe disease. Its main effect is to combat the worsening of the health conditions of infected people.
The drug is for individual oral use, but is not suitable for people under 18 years of age. There is also no indication for pregnant women or people who can or intend to become pregnant during treatment.
The director of Anvisa Meiruze Souza Freitas evaluated that the benefits of releasing the drug outweigh the risks. She added that the anticipation of products to treat covid-19 is in line with the guarantee of treatment possibilities against the disease, considering the situation of the pandemic in Brazil.
“With the pandemic we face unprecedented challenges. Improving this gap is a public health priority. The availability of essential medicines remains insufficient for various reasons, such as high prices, poor purchase and distribution, uncertain product quality and inadequate prescription,” said Meiruze Freitas.
The director of Anvisa Rômison Mota highlighted that it is not a drug for prevention, and that it has already been approved in other countries such as the United States, Canada and Mexico.
The director of Anvisa Alex Campos recalled that it is not a substitute for the vaccine, which is available for free, while Paxlovid, at first, will be marketed, depending on purchasing power for consumption.
Director Cristiane Jourdan pointed out that the data show benefits outweighing the risks and that the risk management measures are compatible with the measures used in the market.
Anvisa’s technical team pointed out risks to be monitored in the concomitant use with other products. “Requirements were made to include contraindications for concomitant use with the drug apalutamide in the package insert”, informed the manager of Pharmacovigilance, Helaine Capucho.
The manager listed points made by Anvisa, incorporated in the risk management plan and in the drug leaflet. The Anvisa team determined that a letter should be sent to health professionals for guidance on the uses of Paxlovid with other medicines and the necessary care. The company was also requested to provide information about the use of the product in Brazil to monitor its application and possible adverse events.
“We included the commitment to present clinical and non-clinical study reports and quarterly report the regulatory situation in other countries”, said Gustavo Mendes, general manager of Medicines and Biological Products at Anvisa.