Gilead Sciences has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its antiviral drug remdesivir, under the brand name Veklury, to treat Covid-19 infection.
The decision falls under an exceptional approval pathway, which is similar to emergency use authorisation in the US.
Remdesivir is an experimental nucleotide analogue that showed broad-spectrum antiviral activity against various viral pathogens, including Ebola, Marburg, MERS and SARS, in-vitro and in-vivo in animal models.
In-vitro testing found that the drug is active against SARS-CoV-2, the novel coronavirus that causes Covid-19. The drug is currently being assessed in several Phase III clinical trials.
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.
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By GlobalData“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.”
The Japanese approval is supported by results from the US National Institute of Allergy and Infectious Diseases (NIAID)’s global Phase III trial and Gilead’s Phase III SIMPLE trial in patients with severe Covid-19 manifestations.
Preliminary data from NIAID’s study, called ACTT, showed a 31% faster time to recovery in patients treated with Gilead’s drug when compared to placebo.
According to the top-line results from Gilead’s SIMPLE study, patients on a ten-day treatment course experienced an improvement in a clinical status similar to those on a five-day dosing course.
In addition, the MHLW based its decision on available data from Gilead’s compassionate use programme, which also involved patients in Japan.
Remdesivir is yet to be licensed or approved outside of Japan and Gilead is working with regulatory authorities globally to facilitate appropriate access to the drug.
