August 10 start of Avigan trials in Philippines not yet final, DOH clarifies

The Department of Health (DOH) on Friday noon clarified that the August 10 start of clinical trials in the Philippines of the Japanese anti-viral flu drug Avigan is not yet final, saying legal documents have yet to be finalized.

"Yung una sinabi namin August 10 tayo mag-start pero hindi pa kasi namin, hindi pa napa-finalize 'yung legal documents natin so we just want to inform everybody kapag talagang final na, kung talagang mag-uumpisa na tayo," said DOH Undersecretary Maria Rosario Vergeire said at a virtual forum.

"But it's going to happen soon," she added.

The August 10 date was mentioned by Vergeire earlier in the day during an interview on Unang  Hirit.

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.

But in Japan, it is only approved for use in flu outbreaks that aren't 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.

Vergeire, during the Unang Hirit interview, said Avigan will undergo a relaxed regulatory process from the Food and Drug Administration (FDA) as it has already been approved by Japanese health authorities.

"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] but this trial has been approved by FDA and ethics review board."

The Philippines has received around 199,000 Avigan tablets from Japan for the trials.—KBK, GMA News