The US FDA has expanded the indication of remdesivir to include hospitalized Covid-positive children, aged ≥28 days with minimum body weight 3 kg. It has also been approved for use in nonhospitalized children who have mild-to-moderate Covid-19 and are at high risk for severe disease, including hospitalization or death. Only the injectable formulation has been approved.

Remdesivir had earlier been approved for use in adults and children older than 12 years weighing at least 40 kgs. With the latest approval, remdesivir becomes the first and only approved treatment for children younger than 12 years.

The FDA has also listed the possible adverse effects of remdesivir such as allergic reactions, fever, difficulty in breathing, rash, nausea, sweating, shivering or elevated liver enzymes. The drug is contraindicated in patients who are allergic to remdesivir or any of its components.

This approval is based on data from trials in adults and the results of the phase II/III CARAVAN trial, which examined the safety, tolerability, pharmacokinetics and efficacy of remdesivir in participants from birth to less than 18 years. The trial demonstrated that the drug was well-tolerated in this age group and a large percentage of study subjects showed clinical improvement and recovery.

In October 2020, the FDA had approved remdesivir for use in hospitalized patients with Covid-19. In January this year, it also approved it for use in non-hospitalized patients aged 12 years and older at risk of severe disease.

(Source: US FDA, April 25, 2022)