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• The approval is based on NIAID led P-III SIMPLE study assessing Veklury in patients with severe manifestations of COVID-19- and available data from Gilead’s compassionate use program including patients in Japan
• The exceptional approval follows EUA- granted to the remdesivir in the US. The therapy is not yet licensed or approved outside Japan and the ongoing clinical studies will continue to evaluate the safety and efficacy of the therapy
• Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro / in vivo in animal models against multiple emerging viral pathogens- including Ebola- Marburg- MERS and SARS

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