Brazil sanitary agency Anvisa approves new drug for COVID-19 treatment
Brazil’s national drug authority Anvisa on Wednesday (Mar. 30) granted emergency authorization to COVID-19 treatment drug Paxlovid, a combination of nirmatrelvir and ritonavir. The product is manufactured by pharmaceutical company Wyeth.
The drug is indicated for positive-testing adults not requiring oxygen and face the risk of developing a severe case of the disease. Its main goal is to prevent the deterioration of the health conditions of those infected.
The drug is meant for individual oral use, but not recommended for patients aged under 18. It is also not indicated for pregnant women or those intending to become pregnant during treatment.
Anvisa Director Meiruze Souza Freitas argued the benefits of releasing the drug outweigh the risks. The early approval of products to treat COVID-19, she went on to note, is in line with the guarantee of treatment possibilities against the disease, considering the pandemic situation in Brazil.
“With the pandemic, we are facing unprecedented challenges. Bridging this gap is a public health priority. The availability of essential drugs remains insufficient due to a number of reasons—high prices, poor purchasing and distribution conditions, uncertain product quality, and inadequate prescriptions,” said Meiruze Freitas.
Management
According to Drug Surveillance Manager Helaine Capucho, “demands were made to include contraindications for simultaneous use with apalutamide in the package insert.”
She also listed issues incorporated into the risk management plan as well as in the drug’s package insert, like the stipulation that a letter must be sent to health professionals for guidance regarding the use of Paxlovid in combination with other drugs and the all necessary care.
In addition, the pharmaceutical company should provide information on the use of the product in Brazil in order to monitor its application and possible adverse events.
