On October 22, the U.S. Food and Drug Administration (FDA) approved the antiviral drug remdesivir (Veklury) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kg for the treatment of COVID-19 requiring hospitalization.
Remdesivir should only be administered in a hospital or in a health-care setting capable of providing acute care comparable to inpatient hospital care. The agent is the first treatment for COVID-19 to receive FDA approval.
Stephen M. Hahn, MD
“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” said FDA Commissioner Stephen M. Hahn, MD. “[This] approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”
The approval of remdesivir was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild to severe COVID-19.
One randomized, double-blind, placebo-controlled clinical trial (ACTT-1), conducted by the National Institute of Allergy and Infectious Diseases, evaluated how long it took for patients to recover from COVID-19 within 29 days of being treated. The trial looked at 1,062 hospitalized patients with mild, moderate, and severe COVID-19 who received remdesivir (n = 541) or placebo (n = 521) plus standard of care. Recovery was defined as either being discharged from the hospital, or being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care.
The median time to recovery from COVID-19 was 10 days for the remdesivir group compared to 15 days for the placebo group, a statistically significant difference. Overall, the odds of clinical improvement at day 15 were also statistically significantly higher in the remdesivir group when compared to the placebo group.
A second randomized, open-label, multicenter clinical trial of hospitalized adult patients with moderate COVID-19 compared treatment with remdesivir for 5 days (n = 191) and treatment with remdesivir for 10 days (n = 193) with standard of care (n = 200). Researchers evaluated the clinical status of participants on day 11.
Overall, the odds of a patient’s COVID-19 symptoms improving were statistically significantly higher in the 5-day remdesivir group at day 11, compared to those receiving only standard of care. The odds of improvement in the 10-day treatment group (compared to those receiving only standard of care) were numerically favorable, but not statistically significantly different.
A third randomized, open-label, multicenter clinical trial of hospitalized adult patients with severe COVID-19 infection compared treatment with remdesivir for 5 days (n = 200) and treatment with remdesivir for 10 days (n = 197). Researchers evaluated the clinical status of patients on day 14. Overall, the odds of a patient’s COVID-19 symptoms improving were similar for those in the 5-day group compared to those in the 10-day group, and there were no statistically significant differences in recovery rates or mortality rates between the two groups.
Dosing and Safety Information
Important information about using remdesivir to treat COVID-19 for its approved use is available in the prescribing information, which includes dosing instructions, potential side effects, and drug interactions. Possible side effects include increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (eg, lips, around eyes, under the skin), rash, nausea, sweating, or shivering. Similar safety information about using remdesivir to treat COVID-19 in certain hospitalized pediatric patients under the Emergency Use Authorization is available in the fact sheets for health-care providers and patients/caregivers.
The FDA granted this application Fast Track and Priority Review designations. The Agency also granted this application a Material Threat Medical Countermeasure Priority Review Voucher, which provides additional incentives for certain medical products intended to treat or prevent harm from specific chemical, biologic, radiologic, and nuclear threats.
This approval does not include the entire population that had been authorized to use remdesivir under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the authorization for remdesivir to authorize the drug’s use for treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. Clinical trials assessing the safety and efficacy of remdesivir in this pediatric patient population are ongoing.
The FDA granted approval and reissued the revised EUA to Gilead Sciences, Inc.