Remdesivir Becomes First Fully FDA-Approved COVID-19 Treatment in US


The full approval is based on 3 randomized controlled trials showing benefit of remdesivir compared with placebo across multiple outcome assessments.

The US Food and Drug Administration (FDA) announced Thursday it has approved Gilead Sciences’ remdesivir (Veklury®) for the treatment of coronavirus disease 2019 (COVID-19).

The drug, which is indicated for adults and children 12 and older who require hospitalization, is now the first and only agent that is fully approved in the United States to treat patients with COVID-19 who require hospitalization.

“Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis,” Gilead CEO Daniel O’Day said in a statement. “It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need.”

The FDA issued an Emergency Use Authorization (EUA) for the antiviral in May based on results from the Phase 3 SIMPLE trial evaluating remdesivir in hospitalized patients with moderate COVID-19 pneumonia, as well as results from the National Institute of Allergy and Infectious Diseases (NIAID) ACTT-1 trial in hospitalized patients with a range of disease severity.

The full approval is based on 3 randomized controlled trials showing benefit of remdesivir compared with placebo across multiple outcome assessments.

The antiviral agent's pathway and role in COVID-19 care has been subject to inconsistent clinical reception. Recent trials, including findings from the ACTT-2 study showed its benefits in reduced hospitalization duration and mortality risk in severely ill patients were more pronounced when used in combination with standard care.

Remdesivir has also been grouped with other antiviral agents including hydroxychloroquine and lopinavir, which all were shown in SOLIDARITY findings from the World Health Organization (WHO) just last week to came up short in providing significant benefit in overall mortality, ventilation need, and duration of hospital stay in severely ill patients with COVID-19 across the globe.

“The unpromising overall findings from the regimens tested suffice to refute early hopes, based on smaller or non-randomized studies, that any will substantially reduce inpatient mortality, initiation of ventilation or hospitalization duration,” WHO investigators wrote at the time. “Narrower confidence intervals would be helpful (particularly for remdesivir), but the main need is for better treatments.”

At the time of the SOLIDARITY findings, Jason Pogue, PharmD, BCPS, BCIDP, clinical pharmacist and professor in infectious diseases at the University of Michigan College of Pharmacy, told Contagion® there is “no way around” these major outcomes.

“This is a very disappointing result,” he said. “It really throws into question what role, if any, remdesivir has in the management of hospitalized patients with COVID-19, particularly at its current price point.”

The antiviral therapy also made headlines when it was among the daily treatment regimen President Donald Trump was receiving during his brief hospitalization for worsening COVID-19 symptoms last month.

Indeed, it's been a conflicting series of developments for what was once among the first considered COVID-19 treatment candidates—and is now its very first regulated treatment.

A four-month-old quote from Jason Gallagher, PharmD, Contagion Editor-in-Chief and Clinical Professor at the Temple University College of Pharmacy, in response to then-promising SIMPLE trial results now reads timelessly on the role of remdesivir:

"We have to keep in mind: it’s our first drug, it’s helpful, it’s not perfect," Gallagher said. "We would love for it to be the new penicillin, but it isn’t."

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