WHO warns regulators to consider all available evidence before approving remdesivir for COVID-19

pharmafile | October 26, 2020 | News story | Sales and Marketing COVID, COVID-19, Gilead, coronavirus 

The World Health Organization’s Chief Scientist Soumya Swaminathan has warned that experts and regulators assessing the use of Gilead’s remdesivir should consider all the available evidence before awarding marketing authorisation to treat COVID-19, and not just the FDA’s approval last week. 

This comes after the WHO’s own Solidarity trial found that the drug had “little to no” benefit in treating COVID-19 mortality. Martin Landray, an epidemiologist at the University of Oxford, commented on the study, saying “the absolute numbers of lives saved would be small”, adding: “Remember too that remdesivir is a drug that is given by intravenous infusion for five to 10 days and costs around £2,000 per course. COVID-19 affects millions of people. It is not a rare disease. We need scalable, affordable, and equitable treatments. The WHO Solidarity trial has done the world a huge favour by producing clear, independent, and robust results.”

Swaminathan has warned others to not take the US approval as an indication this drug does treat coronavirus effectively. She said: “We believe our results are robust and we hope that people doing treatment guidelines and regulators around the world will take note of our study results in addition to other evidence.” 

Some have argued that the WHO trial is not conclusive because it was not placebo-controlled or double-blind trial. But it did look at endpoints such as death and progression to ventilation. The FDA approved remdesivir based on evidence from three clinical trials, including one from the US National Institutes of Allergies and Infectious Disease (NIAID). 

This trial found recovery time from coronavirus patients was 10 days for those on remdesivir compared to 15 for those on a placebo; 29-day mortality was 11% in the drug control group versus 15% in the placebo group, although the FDA did not see this as statistically significant. 

Swaminathan has criticised the FDA approval as it used data directly from the drug’s manufacturer Gilead, instead of the WHO’s own findings. 

Conor Kavanagh

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