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Japan follows US with approval for Gilead’s remdesivir in COVID-19

And is Avigan also heading for approval in Japan?

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Japan has authorised the use of Gilead’s antiviral drug remdesivir under the Veklury brand to treat severely-ill coronavirus patients.

The go-ahead from the Ministry of Health, Labour and Welfare (MHLW) was granted under the ‘exceptional approval’ pathway, which references the emergency use authorisation (EUA) for remdesivir in the US, which was granted earlier this month for hospitalised patients with severe COVID-19 disease.

The regulator also took note of data from Gilead’s compassionate-use programme for the drug, which included patients in Japan. In Europe, the EMA has started a rolling review of remdesivir, saying it should allow it to be cleared for use early, but without giving a time frame.

The US regulator has also previously granted emergency-use approval for malaria drugs hydroxychloroquine and chloroquine.

The approvals came after a trial carried out by the US National Institute for Allergy and Infectious Disease (NIAID) showed the drug, originally developed to treat Ebola, shortened the recovery time for patients with COVID-19.

The ACTT trial showed that the antiviral was able to shorten recovery time from about 15 days to 11, although it wasn’t able to show a statistically significant improvement in survival rates.

Coronavirus cases in Japan rose above the 16,000 threshold over the weekend, with fatalities exceeding 600.

“Gilead continues to work with global regulatory authorities to ensure appropriate access to remdesivir,” said the biopharma company in a statement. It has already agreed to donate 1.5 million doses of remdesivir to treat patients, and there is now speculation about how the company will price the drug thereafter.

Avigan also heading for approval?

The Japanese government also said it is considering approving another medication – Toyama Chemical’s Avigan (favipiravir) – which has been approved as a treatment for influenza in Japan since 2014.

Phase 3 trials of Avigan in COVID-19 are already on the go – with results due in June – and the government said in April it intends to buy two million treatment courses after seeing preliminary activity in more than 120 coronavirus patients treated in Japan, as well as data from China suggesting it may help speed recovery.

Meanwhile, Japan is also reported to be about to approve an antibody drug test for SARS-CoV-2, the virus that causes COVID-19, developed by Fujirebio. The diagnostics company says it should be able to supply around 300,000 test kits per week.

Article by
Phil Taylor

11th May 2020

From: Research



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