The US FDA has also expanded the emergency use authorisation of remdesivir to include the treatment of non-hospitalised paediatric patients, below 12 years


US FDA expands Remdesivir approval. (Credit: Myriams-Fotos from Pixabay.)

Gilead Sciences has received the US Food and Drug Administration (FDA) expedited approval for Veklury (remdesivir) to treat non-hospitalised Covid-19 patients, who are at elevated risk of progression.

With the approval of supplemental new drug application (sNDA), remdesivir can be given as a once-daily intravenous (IV) infusion for three days to treat adults and children, aged 12 years and above.

The antiviral drug was previously approved in the US, both as a standalone and in combination with other drugs, for limited use in patients who require hospitalisation.

In addition, the US FDA has expanded the drug’s emergency use authorisation (EUA) to include non-hospitalised at-high-risk paediatric patients, aged below 12 years.

Gilead Sciences chairman and CEO Daniel O’Day 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 hospitalized with the disease.”

The FDA sNDA approval, paediatric EUA expansion and recently updated National Institutes of Health (NIH) Guidelines, are based on results from the Phase 3 PINETREE trial.

The trial evaluated the efficacy and safety of the drug for the treatment of Covid-19 in 562 non-hospitalised patients, at elevated risk for progression to severe disease.

In the study, treatment using Remdesivir met the composite primary endpoint of a statistically significant reduction in risk of Covid-19 related hospitalisation by 87%, compared to placebo.

The drug showed a safety profile that was similar across a variety of outpatient settings in the trial, with no deaths reported, and only nausea and headache being the adverse events.

Remdesivir is not advised for patients with a history of clinically significant hypersensitivity reactions to the drug or any of its components.

Daniel added: “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.”

Remdesivir is a nucleotide analogue that targets viral RNA polymerase to retain antiviral activity against existing SARS-CoV-2 variants of concern.

Gilead developed the drug, considered as a standard of care for the treatment of hospitalised Covid-19 patients, based on more than a decade of antiviral research.

The drug has shown antiviral activity against the Omicron variant in the in-vitro laboratory testing, the company claimed.