On 22 October 2020, the United States Food and Drug Administration (USFDA) granted its approval to remdesivir (antiviral drug) for use in adult and pediatric patients ( age:12 years and older, weight: at least 40 kilograms/about 88 pounds) for combating COVID-19 needing hospitalization.

This drug should only be given in a hospital or in a health care centre that can offer acute care similar to inpatient hospital care. This acceptance does not incorporate the entire population that had been permitted to utilize remdesivir under an Emergency Use Authorization (EUA) initially published on 1 May 2020.

To ascertain continued accessibility to the pediatric population formerly covered under the EUA, the FDA amended remdesivir's EUA to validate the agent’s use for combating suspected or laboratory-verified COVID-19 in hospitalized pediatrics (weight 3.5 kg to less than 40 kg), or hospitalized pediatrics (age less than 12 years of age, weight at least 3.5 kg).

Clinical trials investigating remdesivir's efficacy and safety in this pediatric patient population are currently ongoing. During this public health emergency, the FDA aims to accelerate the availability of COVID-19 therapies.

Remdesivir's acceptance is aided by clinical data from numerous trials that the agency has meticulously evaluated and depicts a vital scientific milestone in this pandemic. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will assist to promptly move novel medical therapeutics to patients, examine their efficacy, and assess if their profits outweigh their risks.

Remdesivir's acceptance was supported by the agency’s evaluation of data from three randomized, controlled analysis that incorporated individuals hospitalized with mild-to-severe coronavirus infection.

The National Institute of Allergy and Infectious Diseases carried out ACTT-1, a double-blind, randomized, placebo-controlled trial. It assessed the time required for the participants to recover from coronavirus infection within 29 days of being monitored. Overall, 1,062 hospitalized subjects having mild, moderate, and severe COVID-19 were enrolled. Participants were administered either remdesivir (n=541) group or placebo (n=521), plus standard of care group.

Recovery was assessed as either discharge of the patient from the hospital or the patient being hospitalized but no longer needing ongoing medical assistance and supplemental oxygen. A statistically significant difference was witnessed in the median time to recovery from COVID-19 in both the groups, as depicted below:

On day 15, the odds of clinical improvement were also remarkably greater in the remdesivir group in comparison with the placebo group.

Another multi-center, randomized, open-label trial explored treatment with remdesivir for five days (N=191) versus remdesivir for 10 days (N=193) versus standard of care (N=200) in hospitalized adult subjects having moderate coronavirus infection. On day 11, the clinical status of subjects was determined.

On day 11, the odds of a patient’s infection symptoms improving were substantially greater in patients administered remdesivir for five days in comparison with those treated with only standard of care therapy.

Both groups (patients treated with remdesivir for 10 days and standard of care) illustrated numerically favorable odds of improvement. However, it was not statistically significantly different.

Another multi-center, randomized, open-label study of hospitalized adults having severe coronavirus infection compared remdesivir therapy for five days (N = 200) versus 10 days (N = 197). On Day 14, the participant's clinical status was determined. In both the groups, the odds of a subject’s COVID-19 symptoms improving were comparable and no vital differences were noted in the mortality rates or recovery rates.

The treatment-emergent adverse effects include raised liver enzymes levels (which may be a sign of hepatic impairment), allergic reactions that may comprise alterations in the heart rate and blood pressure, fever, wheezing, shortness of breath, reduced levels of oxygen in the blood, swelling (around eyes, lips, under the skin), nausea, sweating, shivering, and rashes.

This application received Fast Track and Priority Review designations by the FDA. This application was also given Material Threat Medical Countermeasure Priority Review Voucher, which offers extra incentives for specific medicinal products intended to combat or prevent damage from certain biological, chemical, radiological, and nuclear threats. Thus, remdesivir is the first agent to receive USFDA acceptance for treating COVID-19.