7 May 2020 - - The Japanese Ministry of Health, Labour and Welfare has granted regulatory approval of Veklury (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19, under an exceptional approval pathway, US-based biopharmaceutical company Gilead Sciences, Inc. (NASDAQ: GILD) said.

The exceptional approval was granted due to the COVID-19 pandemic and references the Emergency Use Authorization of remdesivir in the United States.

The approval is based on clinical data from the US National Institute of Allergy and Infectious Diseases' global Phase 3 trial, Gilead's Phase 3 SIMPLE trial in patients with severe manifestations of COVID-19, and available data from Gilead's compassionate use program, including patients in Japan.

Due to the current public health emergency, the US Food and Drug Administration has issued an Emergency Use Authorization for remdesivir for the treatment of COVID-19.

In the United States, remdesivir is an investigational drug that has not been approved by the FDA for any use, and the safety and efficacy of remdesivir for the treatment of COVID-19 has not been established.

The distribution of remdesivir in the United States has been authorised only for the treatment of hospitalised patients with severe COVID-19; please see below for additional important information about the authorized use of remdesivir in the United States.

Remdesivir is not yet licensed or approved outside of Japan and ongoing clinical trials continue to evaluate its safety and efficacy. Gilead continues to work with global regulatory authorities to ensure appropriate access to remdesivir.

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 being evaluated in multiple ongoing Phase 3 clinical trials.

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.

Remdesivir (GS-5734) is authorized for use under an Emergency Use Authorization only for the treatment of patients with suspected or laboratory-confirmed SARS-CoV-2 infection and severe COVID-19. SARS-CoV-2 is the coronavirus that causes COVID-19 disease.

Severe disease is defined as patients with an oxygen saturation ≤ 94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation.

Remdesivir is authorized for adult or pediatric patients who are admitted to a hospital and for whom use of an IV agent is clinically appropriate, as remdesivir must be administered intravenously.

Remdesivir is an investigational drug that has not been approved by the FDA for any use. It is not yet known if remdesivir is safe and effective for the treatment of COVID-19.