Anvisa approves pediatric use of Remdesivir against Covid-19

The National Health Surveillance Agency (Anvisa) approved, this Monday (21), the pediatric use of Remdesivir against Covid-19. The publication confirming the expansion will be published in an extra edition of the Official Gazette.

As defined by the Agency, “infants and children from 28 days old and weighing 3 kg or more, with pneumonia that require supplemental oxygen administration (low- or high-flow oxygen, or other non-invasive ventilation in the initiation of treatment).

Another group contemplated is that of children weighing less than 40 kg who do not need supplemental oxygen, but who are at greater risk of developing the severe form of the disease.

The agency explained that, for approval, clinical data provided by the manufacturing company, Gilead, were evaluated, which demonstrated “clinical benefit without new safety concerns” and expected similar drug action between adults and children.

Other factors taken into account were the favorable manifestation of other regulatory authorities, such as the FDA and EMA, for example, and the current context of the pandemic.

Paxlovid

Another approval made by Anvisa this Monday (21) was the sale of Paxlovid, a drug for the treatment of Covid-19 for adults, in pharmacies and private hospitals. Purchases can only be made with a prescription.

Thus, the supply of the drug to the private market is authorised, with the labeling and leaflet in Portuguese from Portugal and in Spanish. The Agency highlighted, however, that the manufacturer must maintain and prioritize the supply of the Unified Health System (SUS).

The approval took place unanimously by the collegiate board of the body, which also confirmed the extension of the validity of the medicine from 12 months to 18 months.

Understand how Paxlovid works in the treatment of Covid-19.