The Evolution of Veklury in Treating COVID-19

The advent of COVID-19 as a pandemic led to a search for vaccines and treatments. Pharmaceutical companies and researchers quickly went to work trying to meet the needs of those with COVID-19. The U.S. Food and Drug Administration (FDA) was committed to hastening the development and accessibility of COVID-19 treatments.

Initial FDA Guidelines

The first treatment for COVID-19 was Veklury (remdesivir). The FDA gave Emergency Use Authorization¹ (EUA) to Veklury on May 1, 2020. Since the FDA’s EUA, Veklury’s use and FDA status have evolved to help those in need.

The FDA announced on October 22, 2020, that Veklury was approved for use in adults and pediatric patients 12 years and older who weigh at least 88 pounds.¹ The agency’s guidelines stated that the administration of Veklury should be limited to COVID-19 patients hospitalized or in acute care healthcare settings.

When the FDA approved the use of Veklury in October 2022, the agency limited its use. The FDA outlined the requirements pediatric patients must meet before treatment to ensure ongoing access for pediatric patients once covered by the EUA.

Clinical trials were ongoing to study Veklury's safety for patients in the following categories – pediatric and chronic or end-stage kidney disease.

Veklury Use Includes Outpatient Use

The results of clinical trials were promising. People who tested positive for SARS-CoV-2 and have COVID-19 symptoms were soon eligible to receive outpatient treatments. But they must be at a high risk of developing severe COVID-19 symptoms.

Veklury is extended to outpatient use for individuals with COVID-19 symptoms who are 28 days or older and weigh at least 6.6 pounds.² Outpatient recipients are given Veklury intravenously for three days. Medical professionals advise patients to receive the treatment within seven days of coronavirus symptoms. Since Veklury is an intravenous treatment, medical professionals reserve its use to when nirmatrelvirritonavir (Paxlovid) is unsuitable.

Clinical Trials

Globally, clinical trials³ studying the efficacy and safety of Veklury showed promise. Some studies research its effects on Long COVID and its effectiveness when combined with other treatments.

One of the studies has led to the FDA approving Veklury’s use in COVID-19 patients with renal impairment, including those receiving dialysis. Veklury can now be administered without dosage adjustments.

This change wouldn't be possible without the findings from a stage 3 clinical trial named REDPINE. REDPINE’s study objective was to evaluate whether Veklury decreases the risk of death or invasive mechanical ventilation through day 29. The study consisted of patients with severely reduced kidney function. The study’s inclusion criteria included being diagnosed with COVID-19, hospitalization with COVID-19, specific oxygen, and weight levels, and having either severely reduced kidney function or ongoing acute kidney injury.⁴ The interval between COVID-19 symptoms and inclusion in the trial was also defined.

Researchers continue to actively investigate the effectiveness of Veklury alone or combined with another drug for use in immunocompromised people or with chronic diseases like renal failure.