Gilead Sciences gets Veklury FDA approval for non-hospitalized Covid-19 patients

Gilead Sciences has secured expedited approval from the US Food and Drug Administration (FDA) for its nucleotide analog Veklury (remdesivir) for the treatment of non-hospitalized patients at high risk for Covid-19 disease progression.

The Covid-19 drug has been indicated for adults and adolescents.

Veklury has been the antiviral standard of care for the treatment of hospitalized patients with Covid-19. The expanded indication enables remdesivir to be given in qualified outpatient settings that can give daily intravenous (IV) infusions over three consecutive days.

Additionally, the FDA has expanded the pediatric emergency use authorization (EUA) of Veklury to cover non-hospitalized pediatric patients aged less than 12 years of age who are highly prone to disease progression.

Gilead Sciences said that the FDA actions come amid a massive increase in coronavirus cases and the reduced susceptibility to various anti-SARS-CoV-2 monoclonal antibodies (mAbs) because of the Omicron variant.

The US pharma company said that as remdesivir targets the highly conserved viral RNA polymerase, it retains activity against existing SARS-CoV-2 variants of concern. In vitro laboratory testing demonstrated Veklury’s capability of retaining activity against the Omicron variant, said Gilead Sciences.

Gilead Sciences gets Veklury FDA approval for non-hospitalized Covid-19 patients. Image courtesy of Wilfried Pohnke from Pixabay.

The FDA approval for Veklury’s supplemental new drug application (sNDA), its pediatric EUA expansion, and the recently updated treatment guidelines of National Institutes of Health (NIH) for Covid-19 are driven by the findings of the phase 3 PINETREE clinical trial.

The late-stage clinical trial assessed the efficacy and safety of a three-day course of remdesivir for intravenous (IV) use for Covid-19 treatment in non-hospitalized patients having high risk for disease progression.

An analysis of 562 participants assigned randomly in a 1:1 ratio to get Veklury or placebo, showed that treatment with the nucleotide analog led to a statistically significant 87% reduction in risk for the composite primary endpoint of Covid-19 related hospitalization or all-cause death by Day 28, compared with placebo. In the study, no deaths were seen in any of the two arms by Day 28.

Daniel O’Day — Chairman and CEO of 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 hospitalized 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.”

In late 2020, Gilead Sciences bagged remdesivir FDA approval for the treatment of Covid-19 in patients requiring hospitalization.