President Donald Trump and his administration want regulators to give emergency use authorization to a drug to treat Covid-19 despite its having limited supporting data and potentially serious side effects. This time, it’s not the antimalarial hydroxychloroquine, but a flu drug from Japan.
Politico reported Tuesday that Trump is now pushing for the EUA for Avigan (favipiravir), developed by the pharmaceuticals division of Japan’s Fujifilm, following a conversation with Japanese Prime Minister Shinzo Abe. Like hydroxychloroquine and its relative, chloroquine, Avigan is the subject of multiple clinical trials as a potential treatment for Covid-19, but so far has only limited data to demonstrate its efficacy.
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The political news site cited an unnamed official as saying that the White House National Security Council has pushed for the government to accept a donation of Avigan from Japan, which would require an EUA from the Food and Drug Administration. It was reported that the FDA, Fujifilm and Department of Health and Human Services have been discussing potential clinical trials of the drug in the U.S.
Last month, researchers in China published results from a trial of 200 Covid-19 patients in the Chinese cities of Wuhan and Shenzhen who were given a generic version of Avigan, showing that they recovered from fever and cough in a shorter period of time than patients in the control group. A spokesperson for Fujifilm stated at the time that the company could not comment on the study, given that it used a generic, but added that Avigan could have an antiviral effect against viruses other than influenza because its mechanism of action inhibits viral gene replication inside infected cells. A National Institute of Allergy and Infectious Diseases spokesperson said the drug is one of multiple agents under consideration at the agency as potential treatments for Covid-19.
However, the drug also carries some potentially serious side effects, like birth defects. Moreover, South Korea’s drug regulator has opted not to import Avigan for use, citing what it called an insufficient body of data to demonstrate its efficacy.
The administration’s reported favor for Avigan closely follows remarks made by Trump promoting hydroxychloroquine and a related drug, chloroquine, for the treatment of Covid-19. Despite mixed results from two very small clinical trials and their potential to cause serious and even fatal side effects, the FDA granted an EUA for the drugs on Saturday.
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Other drugs currently in clinical development for Covid-19 include Gilead Sciences’ remdesivir, Regeneron Pharmaceuticals and Sanofi’s Kevzara (sarilumab). Gilead is expected to have data for remdesivir this month.
Photo: FDA (free of all copyright protection)
