Clinical trials for Avigan drug delayed

September 2, 2020

The clinical trials for the Japanese flu drug, Avigan, in the Philippines  has yet to begin almost one month since Japan turned over the tablets good for 100 coronavirus disease (COVID-19) patients.

In a virtual press briefing on Wednesday, Department of Health (DOH) Undersecretary Maria Rosario Vergeire said the rescheduled start on September 1 did not materialize.

"It wasn't able to start yesterday (September 1), we suffered another delay (in the Avigan trials)," said Vergeire.

She said officials failed to receive an approval from the ethics board for the participation of Dr. Jose N. Rodriguez Memorial Hospital, Sta. Ana Hospital, and Quirino Memorial Medical Center in the clinical trials.

Vergeire said the Philippine General Hospital, the fourth participant in the medical trials. is still reviewing the memorandum of agreement.

"Once all of these have been processed and have been approved, we will already start," said Vergeire.

The DOH did not say when the Avigan clinical trials will start

On August 6, the Japanese Embassy in the Philippines said its government has  delivered Avigan tablets for 100 patients to the DOH as part of its emergency grant aid to countries severely affected by COVID-19.

The DOH has distributed Avigan tablets to different hospitals.

Vergeire said they distributed 199,000 tablets after they were donated to the National Security Council (NSC) and were handed over to the DOH for distribution to hospitals.

"We have distributed them. These are Chinese brands, not Japanese, as they were donated through our NSC," said Vergeire.

"We distributed them to different hospitals, through the compassionate special permit from the Food and Drug Administration (FDA)," she added.

Under existing guidelines, off-label medicines that are used outside clinical trials must secure compassionate special permit from the FDA.

The DOH reminded the Cavite government it must go through a similar procedure for its planned COVID-19 vaccine trials.

Cavite must undergo the process of regulation and accreditation for the vaccine clinical trials.

"They will undergo the process of regulation, go through the FDA, and the ethics review. Afterwards, they will have to inform the DOH so that they can begin," said Vergeire.

"Nobody can begin any clinical trials without an approval from the FDA and the ethics board," she added.

"The government needs to regulate so that we can ensure that our people will be safe. If it doesn’t undergo through the process, we cannot assure that it won't cause harm to our citizens," said Vergeire. DMS