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September 23, 2020

Fujifilm to seek approval for Avigan in Covid-19 after positive data

Japan's Fujifilm Toyama Chemical plans to seek approval for its anti-viral drug Avigan (favipiravir) to treat patients with Covid-19, after obtaining positive results in a Phase III clinical trial.

Japan’s Fujifilm Toyama Chemical plans to seek approval for its anti-viral drug Avigan (favipiravir) to treat patients with Covid-19, after obtaining positive results in Phase III clinical trial.

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Avigan secured approval in March 2014 for manufacture and sale in Japan to treat influenza infection. The drug selectively blocks RNA polymerase required for influenza virus replication.

The mechanism could have an anti-viral activity on the novel coronavirus, an RNA virus similar to the influenza virus, said Fujifilm.

The company initiated a randomised, placebo-controlled, single-blind comparative Phase III trial in March to assess the safety and efficacy of Avigan in Covid-19 patients with non-severe pneumonia in Japan.

Results showed that the trial met its primary endpoint of time to negative conversion of detectable SARS-CoV 2 viral RNA in the RT-PCR assays, as well as symptoms relief.

With 156 participants as analysis targets, the median value of primary endpoints were 11.9 days in Avigan arm, as well as 14.7 days in placebo group.

Fujifilm added that researchers observed a statistically significant difference between the trial groups, where Avigan led to a shorter time to resolution in patients with non-serious pneumonia when compared to placebo.

Furthermore, the results showed no new safety concerns with the drug. The company will carry out a detailed review of the trial data.

Based on the results, Fujifilm intends to apply for partial changes to add the new indication as early as October.

Fujifilm Group, in alliance with strategic partners, has been working to boost production of Avigan to meet the supply demand by the Japanese government, as well as other countries.

In April, the company said that it is increasing manufacturing capacity at its Fujifilm Wako Pure Chemical facility in Japan. The facility will produce pharmaceutical intermediates required to manufacture Avigan.

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COVID-19 continues to dominate headlines the world over. It has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities.  Faced with an explosion of conflicting information on how to plan and implement successful recovery strategies, decision-makers are in dire need of a single, reliable source of intelligence.   GlobalData’s COVID-19 Executive Briefing gives you access to unparalleled data and insights to successfully navigate the uncertain road to recovery across the world’s largest industries. Understand every aspect of this disruptive theme by delving into: 
  •  COVID-19 infection update, with statistics on the spread, testing by country, as well as the latest data on vaccines and therapeutic developments 
  • Economic impact overview, covering stock market indices, GDP, unemployment rates, policy responses & GlobalData’s economic recovery scorecards 
  • Sector developments, with access to sector insight summaries, cross-sector indices and the leaders and laggards in each industry vertical 
Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today. 
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