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Gilead’s Veklury receives FDA approval for non-hospitalised high-risk patients to treat COVID-19

The FDA also issued an EUA for the treatment to include non-hospitalised paediatric patients 12 years and under who are at high risk of disease progression

Gilead

Gilead Sciences has announced that the US Food and Drug Administration (FDA) has granted a rapid approval of a supplemental drug application for Veklury (remdesivir) for the treatment of non-hospitalised adult patients who are deemed to be at high risk of severe COVID-19.

With the FDA’s approval, Veklury is further expanded, having been used as the antiviral standard of care for patients hospitalised with the virus. The treatment is now allowed to be administered via daily intravenous infusions over the course of three consecutive days in qualified outpatient environments.

In addition, the FDA’s expanded indication of the emergency use authorisation (EUA) for Veklury is set to include non-hospitalised paediatric patients who are 12 years of age and under who are at high risk of disease progression.

The approval follows a rapid increase in COVID-19 cases coupled with the reduced sensitivity to various anti-SARS-CoV-2 monoclonal antibodies due to the recent and highly-transmissible Omicron variant.

Veklury works by targeting the viral RNA polymerase, retaining activity against severe SARS-CoV-2 variants, with in vitro laboratory trials demonstrating Veklury’s effectiveness in retaining activity against the Omicron variant.

So far, there have been no major genetic changes recorded or identified in any existing variants of concern that might significantly change the viral RNA polymerase targeted by Veklury.

Commenting on the approval, Daniel O’Day, chairman and chief executive officer at Gilead Sciences said: “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 hospitalised with the disease.

“While we continue to advance remdesivir to benefit more patients in multiple settings, we are also advancing our investigational oral compounds. These are based on the same antiviral mechanism of action as remdesivir and a phase 1 trial for our oral COVID-19 antiviral, GS-5245, is now underway.”

The FDA’s supplemental new drug application approval and the paediatric EUA expansion have been granted alongside the recently updated National Institutes of Health (NIH) Treatment Guidelines for COVID-19 that recommend Veklury for treatment in non-hospitalised environments. The recommendations are based on results from the PINETREE phase 3, randomised, double-blind, placebo-controlled study.

Article by
Fleur Jeffries

24th January 2022

From: Regulatory

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