Japan approves Gilead's COVID-19 drug remdesivir
Japan’s regulator has quickly approved Gilead’s remdesivir for patients with severe COVID-19, after the FDA allowed its use as an emergency treatment for the disease earlier this month.
The company said the Japanese Ministry of Health, Labour and Welfare has granted regulatory approval of the drug, branded as Veklury, as a treatment for infection with the SARS-CoV-2 virus that causes COVID-19 under an exceptional approval pathway.
This was granted with reference to the Emergency Use Authorization in the US, based on clinical data from a phase 3 trial by the US National Institute of Allergy and Infectious Diseases, and Gilead’s phase 3 SIMPLE trial in severe COVID-19.
It also drew on data from Gilead’s compassionate use programme, including patients in Japan.
Remdesivir is not yet licensed or approved outside of Japan and ongoing clinical trials continue to evaluate its safety and efficacy.
Gilead said it is working with global regulatory authorities to ensure appropriate access to remdesivir.
Last week Gilead announced plans to donate doses of remdesivir to the US government following the emergency approval by the FDA.
On Saturday the US Department of Health and Human Services said it would allow state health departments to distribute remdesivir to fight COVID-19.
The US will receive around 40% of the drug donated to fight the disease, and Gilead has committed to supplying around 607,000 vials to the country in the next six weeks.
Although the FDA has yet to formally review remdesivir it granted the Emergency Use Authorization based on phase 3 data published by the US National Institute for Allergy and Infectious Disease (NIAID) showing that remdesivir helps reduce recovery time in patients hospitalised with serious COVID-19 symptoms.
Median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo, and there was a non-significant trend suggesting a survival benefit.
The FDA also referred to data from Gilead’s phase 3 trial showing that a five-day treatment regimen produced similar effects to a 10-day treatment regimen in seriously ill patients – an important development as it increases the number of patients who could receive the drug.
Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, Marburg, MERS and SARS.
In vitro testing conducted by Gilead has demonstrated that remdesivir is active against the virus that causes COVID-19. The safety and efficacy of remdesivir to treat COVID-19 are still being evaluated in several ongoing phase 3 clinical trials.
