MANILA — Clinical trials for the drug Avigan in the Philippines is still stalled although Japan may be nearing approving it as a COVID-19 treatment.
Asked about its status, Health Undersecretary Maria Rosario Vergeire said they are still waiting for documents to be finalized.
“The clinical trial agreement, we are still waiting this be signed by the Chancellor of UP (University of the Philippines) Manila. Hanggang ngayon nasa kanila pa rin (it is still with them),” she said during a virtual briefing.
The Department of Health earlier said that the Avigan trial will be facilitated by UP’s Philippine General Hospital, Sta. Ana Hospital, Dr. Jose N. Rodriguez Memorial Hospital, and Quirino Memorial Medical Center.
On the other hand, she said 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’re just waiting for the clinical trial agreement). Hopefully by next week we can have this already,” she said.
Food and Drug Administration (FDA) Director General Eric Domingo said during the same briefing that the agency already approved the clinical study back in July.
“If the clinical trials being done in Japan is already conclusive they can use that for registration purposes in the Philippines,” he said.
Fujifilm Holdings Corp. this week said that their Phase III clinical trial showed that Avigan, which was initially made to treat flu, reduced recovery times for COVID-19 patients with moderate symptoms.
The company said it will perform further analysis of the results and will seek approval for the drug’s use in Japan as early as October.
Domingo said while the clinical trials in the Philippines have been delayed, Avigan or favipiravir is already being used in the Philippines for compassionate use. He said though that they don’t expect any preliminary result until midway of the official clinical trial, which is said to last for a year.