Remdesivir first FDA-approved COVID treatment, but only for severe Cases

The US Food and Drug Administration (FDA) approved remdesivir as a treatment for hospitalized COVID-19 patients aged 12 and up. In May 2020, FDA approved remdesivir for severe COVID-19 cases only, under the initial Emergency Use Authorization (EUA). Remdesivir was allowed only for those with low blood oxygen levels or those in need of oxygen therapy or mechanical ventilation.

FDA issued another EUA in August to include all adult and pediatric hospitalized COVID-19 patients regardless of the severity of the case. EUA today allows treatment of hospitalized pediatric patients younger than 12 weighing at least 3.5 kg.

Gilead, the owner of Remdesivir, attributes the approval on three randomized controlled trials. Nonetheless, remsidivir, which will be marketed as Veklury, is advised to be administered in a hospital or in a healthcare setting that is capable of providing acute care comparable to inpatient hospital care.

The studies show that the clinical outcomes of COVID-19 patients improve with a 5-day treatment compared with standard of care (odds ratio of 1.65).

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