Anti-flu drug clinical trials pending as DOH awaits documents

The country has yet to start the conduct of clinical trials for the anti-flu drug Avigan as there are still some documents that need to be accomplished, the Department of Health (DOH) said.

Anti-influenza Avigan Tablets produced by Japan's Fujifilm are displayed in Tokyo on Oct. 22, 2014. (AFP/Kazuhiro Nogi / MANILA BULLETIN)

“We are just waiting for the finalization of the documents, yung clinical trial agreement at yung iba pang mga documents,” said DOH Undersecretary Maria Rosario Vergeire in an online forum Friday.

“Ito na lang pong ating clinical trial agreement ang ating inaantay. So hopefully by next week we can have this already,” she added.

Food and Drug Administration (FDA) Director General Rolando Enrique Domingo said that his agency already approved the conduct of a clinical trial for Avigan last July.

To note, the Avigan trial is expected to be held in the Philippine General Hospital, Sta. Ana Hospital, Dr. Jose N. Rodriguez Memorial Hospital, and Quirino Memorial Medical Center, wherein a total of 100 patients are expected to participate.

Meanwhile, the developments in the clinical study of Avigan in Japan may be used for its 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. It will make it easier and faster to register the product,” said Domingo.