Japan grants 'exceptional' approval for remdesivir in COVID-19

As had been widely expected, Gilead Sciences (Nasdaq: GILD) on Thursday announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted regulatory approval of remdesivir – which has now been given the trade name Veklury - as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19, under an exceptional approval pathway.

The exceptional approval, coming just three days after the US firm filed for fast-track approval for the treatment, was granted due to the COVID-19 pandemic and references the Emergency Use Authorization of remdesivir in the USA last week. This makes Veklury the first officially-authorized drug for the disease in Japan.

Typically, approval of new drugs in Japan requires clinical trials to be conducted in the Japanese population. The country’s Prime Minister, Shinzo Abe, has been supporting urgent approval of potential treatments to tackle the COVID-19 pandemic and has previously said that he also expects Fujifilm Toyama Chemical’s influenza antiviral drug Avigan (favipiravir) to be approved for treating patients with COVID-19, by the end of this month.