WHO backs off on remdesivir as FDA issues another EUA

Regulatory NewsRegulatory News | 19 November 2020 |  By 

The World Health Organization is recommending against the use of the antiviral remdesivir (Veklury, Gilead) for the treatment of COVID-19.
“The antiviral drug remdesivir is not suggested for patients admitted to hospital with COVID-19, regardless of how severely ill they are, because there is currently no evidence that it improves survival or the need for ventilation,” according to the World Health Organization’s (WHO’s) Guideline Development Group, in a statement released by WHO on 19 November.
The expert panel’s updated living guideline for the use of drugs in COVID-19 appeared in BMJ. The investigators said that the living guideline took into account ongoing results from the WHO SOLIDARITY trial that follows patients who are hospitalized with COVID-19 and receive therapies under investigation, including remdesivir.
Their recommendation, said the guideline group, was also “informed by results from a systematic review and network meta-analysis that pooled data from four randomized trials with 7333 participants hospitalized for COVID-19.”
However, the recommendation against using remdesivir was overall based on low-certainty evidence for the outcomes of interest, so the panel clarified that the available evidence does not definitively prove that remdesivir has no benefit in the treatment of COVID-19. Rather, they said, they could not find evidence that it did improve outcomes.
“But given the remaining possibility of important harm, as well as the relatively high cost and resource implications associated with remdesivir (it must be given intravenously), they judged this to be an appropriate recommendation,” said WHO in announcing the panel’s recommendations.
 The WHO investigators noted that they did not investigate the use of remdesivir in children with COVID-19, and that there were some data that indicated benefit of remdesivir in non-critically ill patients with COVID-19.
On the same day that WHO issued its recommendations against use of remdesivir for COVID-19, the US FDA issued a new emergency use authorization (EUA) for remdesivir in combination with an immunomodulator. The new EUA endorses the combination of baracitinib and remdesivir to treat COVID-19 in hospitalized patients who have supplementary oxygen requirements or who are ventilated or receiving extracorporeal membrane oxygenation (ECMO).
FDA said it was basing the EUA on one clinical trial showing that the combination of the Janus kinase inhibitor baracitinib plus the antiviral remdesivir reduced time to recovery at the 29-day mark compared with patients who received remdesivir plus placebo. Patients in the intervention arm recovered one day sooner than those in the trial arm (7 versus 8 days), a statistically significant difference.
Patients were also significantly less likely to be dead or ventilated at day 29 if they received the intervention, and they were more likely to be clinically improved at 15 days if they received baricitinib, said FDA.
The trial was a double-blind trial of 1,033 patients with moderate or severe COVID-19 randomized 1:1 to receive baracitinib plus remdesivir or remdesivir plus placebo; the trial was conducted by the National Institute of Allergy and Infectious Diseases.
“The FDA’s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalized patients, and FDA’s first authorization of a drug that acts on the inflammation pathway,” said Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research in announcing the EUA. “Despite advances in the management of COVID-19 infection since the onset of the pandemic, we need more therapies to accelerate recovery and additional clinical research will be essential to identifying therapies that slow disease progression and lower mortality in the sicker patients.”
WHO BMJ article


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Tags: coronavirus, FDA, US, WHO

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