Avigan’s PH trial further delayed, while Japan tests show effectiveness for COVID-19

MANILA – Clinical trials for the drug Avigan in the Philippines are still stalled, although Japan may be about to approve it as a treatment for COVID-19.

Asked about her status, the Undersecretary of Health, María Rosario Vergeire, said that they are still waiting for the documents to be finalized.

“The clinical trial agreement, we are still waiting for it to be signed by the rector of UP (University of the Philippines) Manila. Hanggang ngayon nasa kanila pa rin (is still with them), ”he said during a virtual briefing.

The Health Department previously said that the Avigan trial will be facilitated by UP Philippine General Hospital, Sta. Ana Hospital, Dr. José N. Rodríguez Memorial Hospital and Quirino Memorial Medical Center.

On the other hand, he said that the memorandum of agreement with the Department of Science and Technology – Philippine Council for Health Research and Development is already done.

“Ito na lang pong ating Clinical Trial Agreement Ang inaantay (We are waiting for the clinical trial agreement). Hopefully next week we can have this, ”he said.

The Director General of the Food and Drug Administration (FDA), Eric Domingo, said during the same briefing that the agency already approved the clinical study in July.

“If the clinical trials that are being done in Japan are already conclusive, they can use them for registration purposes in the Philippines,” he said.

Fujifilm Holdings Corp. said this week that its Phase III clinical trial showed that Avigan, which was initially made to treat the flu, reduced recovery times for COVID-19 patients with moderate symptoms.

The company said it will conduct a more detailed analysis of the results and seek approval for the drug’s use in Japan starting in October.

Domingo said that while clinical trials in the Philippines have been delayed, Avigan or favipiravir are already being used in the Philippines for compassionate use. However, he said they do not expect any preliminary results until the middle of the official clinical trial, which is said to last a year.