The regulatory approval is based on data from the US National Institute of Allergy and Infectious Diseases’ Phase 3 trial, and Gilead’s Phase 3 SIMPLE trial
Government office complex in Kasumigaseki, Tokyo, Japan. (Credit: BlackRiver/Wikipedia.)
US-based biopharmaceutical firm Gilead Sciences has secured the regulatory approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Veklury (remdesivir) to treat SARS-CoV-2 infection, which causes Covid-19.
The company said that the Japanese regulatory approval for Veklury was granted under an exceptional approval pathway, amid Covid-19 pandemic.
In addition, the drug has been granted Emergency Use Authorisation to treat patients with suspected or laboratory-confirmed SARS-CoV-2 infection and Covid-19 in the US.
Gilead Sciences chief medical officer Merdad Parsey said: “The Japanese approval of remdesivir 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.
“We thank the Japanese Ministry of Health, Labour and Welfare for their leadership and collaboration, as we together work to respond to this public health emergency.”
Veklury is being evaluated in several Phase 3 clinical trials to treat Covid-19
Veklury is an investigational nucleotide analogue with antiviral activity in animal models against multiple emerging viral pathogens, including Ebola, Marburg, MERS and SARS.
The US-based biopharmaceutical firm has conducted in-vitro testing, which demonstrated that Veklury is active against the virus that causes Covid-19. The safety and efficacy of Veklury to treat Covid-19 are being evaluated in several ongoing Phase 3 clinical trials.
The regulatory approval is based on the clinical data from the US National Institute of Allergy and Infectious Diseases’ global Phase 3 trial, Gilead’s Phase 3 SIMPLE trial, and data from the company’s compassionate use programme on patients in Japan.
Remdesivir is an investigational drug that has not been approved by the FDA for any use, and the distribution of the drug in the US is authorised only for the treatment of hospitalised Covid-19 patients.
Gilead Sciences is engaged in discovering, developing and commercialising advanced medicines in areas of unmet medical need.