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The Food and Drug Administration (FDA) announced two decisions last week to allow for the use of remdesivir in certain adult and pediatric patients, even if they have not yet been hospitalized.
The FDA expanded the approved indication for the use of remdesivir for some outpatients who are over the age of 12, have mild-to-moderate COVID-19, and are not yet hospitalized, but are considered to be at high risk of developing a more severe case of COVID-19.
The FDA also expanded their Emergency Use Authorization (EUA) for remdesivir to authorize giving the drug to certain younger pediatric patients before hospitalization.
The use of the antiviral drug from Gilead Sciences, sold under the brand name of Veklury, was previously limited only to patients requiring hospitalization.
The FDA said its approval was based on results from the PINETREE phase 3 randomized, placebo-controlled, double-blind clinical trial, which included 562 non-hospitalized patients with mild-to-moderate COVID-19 infections. The result reportedly showed that the drug significantly reduced the risk of hospitalization by 87% compared with a placebo.
As FDA noted, “2 of 279 patients who received Veklury (0.7%) required COVID-19 related hospitalization compared to 15 of 283 patients who received a placebo (5.3%). There were no deaths in either group.”
Tests show effectiveness against Omicron
Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in the FDA announcement that the agency’s actions “bolster the arsenal of therapeutics to treat COVID-19 and respond to the surge of the Omicron variant.”
A statement from Gilead, a BIO member, said remdesivir gains importance amidst the surge in COVID-19 cases and in light of FDA’s decision to limit use of Regeneron and Eli Lilly’s monoclonal antibody treatments for patients with the Omicron variant. (See story here.)
Unlike those treatments, “remdesivir targets the highly conserved viral RNA polymerase, thereby retaining activity against existing SARS-CoV-2 variants of concern,” including Omicron, the company said in its press release. It added that, during the in-vitro laboratory testing, “no major genetic changes have been identified in any of the known variants of concern that would significantly alter the viral RNA polymerase targeted by remdesivir.”
