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Remdesivir: FDA Approved for COVID-19

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Remdesivir 100 mg Infusion - Approved dose for COVID-19

Drug is first to receive FDA endorsement for treatment of COVID-19 requiring hospitalization.

On Thursday, October 22, the Food and Drug Administration formally approved remdesivir to treat COVID-19 disease.

The treatment is approved for adults and children 12 years of age and older, weighing at least 88 pounds.  Remdesivir had previously been available under an Emergency Use Authorization (EUA) issued on May 1, 2020.

Remdesivir has broad antiviral activity against RNA viruses, including the coronaviruses. In studies, the drug has demonstrated inhibitory activity against SARS-CoV-1 and Middle East respiratory syndrome (MERS-CoV).

ACTT-1: Final Report

In the large double-blind, randomized, placebo-controlled trial, the Adaptive COVID-19 Treatment Trial (ACTT-1), 1,062 hospitalized subjects with mild, moderate and severe COVID-19, subjects received either remdesivir or placebo plus standard of care.

The median time to recovery for the remdesivir group was 10 days, compared to 15 days for the placebo group. Overall, the odds of clinical improvement at Day 15 were significantly higher in the remdesivir group when compared to the placebo group.

Final trial results were reported in the New England Journal of Medicine in early October, Remdesivir for the Treatment of Covid-19 — Final Report.

In order to ensure access to the pediatric population previously covered under the EUA, the FDA revised the EUA for remdesivir to authorize the drug’s continued use for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients within certain weight guidelines.

Clinical trials to assess the safety and efficacy of remdesivir in this pediatric patient population are ongoing.

“Today’s 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,” said FDA Commissioner Stephen M. Hahn, MD. “The agency will to 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.”

Dr. Hahn is the former Chair of Radiation-Oncology at the Abramson Cancer Center in Philadelphia.

Remdesivir for COVID-19

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 (e.g., 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 EUA is available in the fact sheets for health care providers and patients/caregivers.

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