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2022-01-24| Trials & Approvals

Remdesivir Cleared for Treating Non-Hospitalized COVID-19 Patients

by Joy Lin
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The FDA has approved the supplemental new drug application for remdesivir for the treatment of non-hospitalized Covid-19 patients who are at high risk of progressing to severe disease, which includes hospitalization and death. Developed by Gilead Sciences and sold under the brand name “Veklury”, remdesivir was originally approved to treat hospitalized Covid-19 patients. 

The expanded indication allows remdesivir to be used in qualified outpatient settings that can administer daily intravenous (IV) infusions over three consecutive days.

In addition, the FDA also expanded the pediatric emergency use authorization (EUA) of remdesivir to include high-risk non-hospitalized patients younger than 12. 

The approval comes as the US grapples with a surge in Covid-19 cases fuelled by the Omicron variant, which has rendered several Covid-19 monoclonal antibody treatments, such as the one produced by Regeneron and Eli Lilly, ineffective. 

Related Article: FDA Grants Emergency Use Authorization to Third COVID-19 Antibody Therapy

How Remdesivir Works

 

Remdesivir works by disrupting viral replication. The drug is a nucleotide analog that acts like the chemical building blocks of a DNA or RNA sequence. When viral RNA polymerase reads a strand with remdesivir inserted in it, the polymerase stops or produces a defective product.  

As remdesivir targets the highly-conserved viral RNA polymerase, it retains activity across Covid-19 variants. In vitro studies have also confirmed that remdesivir retains activity against the Omicron variant. 

Related Article: Brii Bio’s COVID-19 Antibody Cocktail Sees Promising Results in Phase 3 ACTIV-2 Trial

Remdesivir Reduced Severe Disease Risk by 87%: Study

 

The expanded approval of remdesivir was based on results from the PINETREE Phase 3 study. The randomized, double-blind, placebo-controlled trial tested the efficacy and safety of a three-day IV course of remdesivir in non-hospitalized Covid-19 patients. 

According to the results, treatment with remdesivir significantly reduced the risk of hospitalization or death from Covid-19 by 87% by Day 28 compared to placebo.

Common side effects of remdesivir included nausea and headache. 

 

Oral Covid-19 Antivirals that Work Like Remdesivir

 

“Remdesivir has now helped to treat more than 10 million people around the world with Covid-19 and continues to play a key role in helping to reduce the burden of the pandemic. Based on the most recent data, we now understand that remdesivir is also effective in the early stages of Covid-19 infection, in addition to helping patients who are hospitalized with the disease,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead. 

Besides expanding indications for remdesivir, Gilead is also working on investigational oral compounds that work like remdesivir, with a Phase 1 trial of lead candidate GS-5245 underway, added O’Day.

Related Article: GeneOnline’s Pick: Notable Novel FDA Approved Drugs in 2021

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