By John Clifford Lintao
CLINICAL trials of the Japanese anti-viral flu drug Avigan among Filipino COVID-19 patients will start on Monday, Aug. 10, said Health Undersecretary Maria Rosario Vergeire.
Vergeire hinted on an all-set-up plan for the trial following the arrival of 199,000 Avigan tablets from Japan for the trials.
“We have identified site na hospital kung saan gagamitin ito. We will already start on August 10 for this Avigan trial so abangan na lang po natin, nandito na naman po ‘yung mga gamot,” she said.
Avigan is the brand name of the drug favipiravir. It was developed by what is now known as Fujifilm Toyama Chemical and approved for use in Japan in 2014.
Interestingly, the Japanese government approved its use in flu outbreaks which are not being effectively addressed by existing medications. It is not available on the market and can only be manufactured and distributed at the request of the Japanese government.
Unlike any other medicines, Avigan no longer needs approval of the Food and Drug Administration (FDA) as it has already been approved by Japanese health authorities, Vergeire added.
“Avigan has been approved by FDA for long kasi ginagamit na ho talaga iyan sa flu, so ‘yan naman ay meron na. Hindi po ng FDA natin but FDA ng Japan,” she said.
“Kaya pagpasok dito wala na ho tayo masyadong regulatory processes na mangyayari because it’s been approved [already].”
According to a statement from the Japanese Embassy in Manila, Avigan tablets will be tested on 100 patients in the Philippines and that the donation of the drug is part of its emergency grant aid to countries severely affected by COVID-19.
Each recipient government, it said, “has acknowledged Avigan’s proper usage and prescription in view of its known adverse side effects.”
Clinical trials of Avigan came amid spike in COVID-19 infection in the Philippines, which is now a virus hot spot in Southeast Asia, overtaking Indonesia Thursday with 119,460 infections.
President Rodrigo Duterte had reported to Congress in May that some P18 million will be spent by the Department of Health (DOH) for clinical trials on Avigan on treating patients with COVID-19.