Japan grants "exceptional approval" to Gilead's remdesivir for patients with severe COVID-19

Gilead Sciences announced Thursday that Japanese regulators have authorised use of remdesivir under an exceptional approval pathway as a treatment for patients with severe SARS-CoV-2 infection. Gilead noted that approval for the antiviral medicine, which will be marketed in the country under the name Veklury, was granted due to the COVID-19 pandemic and also references the emergency-use authorisation that was recently granted for the drug in the US.

The latest approval "is in recognition of the urgent need to treat critically ill patients in Japan. It is a reflection of the exceptional circumstances of this pandemic," commented Merdad Parsey, chief medical officer at Gilead.

According to the company, the decision is based in part on data from the global Phase III ACTT trial, which is being led by the US National Institute of Allergy and Infectious Diseases (NIAID). Preliminary findings released last week demonstrated that hospitalised patients with advanced COVID-19 given the drug had a 31% faster time to recovery than those on placebo, with median recovery times being 11 days and 15 days, respectively. 

Japanese approval was also backed by results from Gilead's Phase III SIMPLE trial in patients with severe manifestations of COVID-19, as well as available data from the company's compassionate-use programme, including patients in Japan. Last week, Gilead said data from the SIMPLE study indicated that five-day dosing of remdesivir led to "similar improvement in clinical status" as the 10-day treatment course being evaluated in the NIAID study and other ongoing trials. 

Gilead added that it continues to work with global regulatory authorities to "ensure appropriate access to remdesivir." Earlier this week, CEO Daniel O'Day stated "we've donated the entire supply [of remdesivir] that we have within our supply chain." The company has said it expects to produce more than 140,000 rounds of its 10-day treatment regimen by the end of May and anticipates it can make 1 million rounds by the end of this year. 

For related analysis, see ViewPoints: Remdesivir reality sinks in for Gilead. See also ViewPoints: Something is better than nothing – the remdesivir story.

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