FDA says Japanese flu drug may be used sans trials

WITH or without the conduct of clinical trials in the country, Japanese flu drug Avigan may soon be used in the Philippines to treat coronavirus disease 2019 (Covid-19), according to the Food and Drug Administration (FDA).

FDA Director General Eric Domingo said Friday, September 25, 2020, that the drug manufacturer or distributor may already apply for registration in the Philippines.

"If the clinical trials that are being done in Japan are already conclusive, then they can use that for registration purposes here in the Philippines," Domingo said during the Department of Health (DOH) online media forum on Friday.

"It’ll make it easier and faster to register the product," he added.

Once the FDA issues a special permit, Avigan may already be administered to Covid-19 patients.

"We do have compassionate permits for Avigan, for favipiravir," said Domingo.

Avigan tablets good for 100 patients arrived in early August, but could not be used because the DOH is still waiting for the completion of all the legal documents needed before the trial begins.

"We are just waiting for the finalization of the documents of the clinical trial agreements," said DOH Undersecretary Maria Rosario Vergeire in the same press briefing.

"So hopefully, by next week, we can have this already," she added.

Clinical trials for Avigan as Covid-19 treatment are set to be held in four hospitals, namely the Philippine General Hospital, Sta. Ana Hospital, Dr. Jose N. Rodriguez Memorial Hospital, and Quirino Memorial Medical Center. (HDT/SunStar Philippines)


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