COVID treatment drug bexovid for mild, moderate cases: FDA

Gillan Ropero, ABS-CBN News

Posted at Jan 13 2022 12:13 PM | Updated as of Jan 13 2022 02:15 PM

MANILA - The public may access COVID-19 treatment drug bexovid, the generic version of Pfizer's Paxlovid, through the Department of Health and a prescription of their doctor, the Food and Drug Administration said Thursday.

The FDA had granted bexovid a compassionate special permit, its officer-in-charge Oscar Gutierrez told President Rodrigo Duterte in a taped briefing on Monday night.

The drug is intended for mild to moderate virus patients aged 12 and above, Gutierrez said.

"Itong bexovid po ay prescription drug po ito. Ito pong gamot na ito ay maa-access natin sa Department of Health. So makipag-uganyan po sila sa DOH at sa mga doctor para mai-prescribe ito," he said in a virtual press briefing Thursday.

(Bexovid is a prescription drug. It can be accessed through the Department of Health. The public needs to coordinate with the DOH and their doctor to get a prescription.)

The health agency had applied for a CSP for bexovid, according to Gutierrez.

"Merong isang bansa, isang manufacturer, na nag-produce ng generic equivalent. It so happens na itong manufacturer na ito, merong foreign GMP (Good Manufacturing Practice) clearance sa atin," he said.

(There's one country, a manufacturer that produced a generic equivalent, and it so happens this manufacturer has foreign GMP (Good Manufacturing Practice) clearance here.)

"In-evaluate ng Center for Drug Regulation Research. Mukhang under CSP, ito po ay compliant naman sa requirements ng FDA kaya na-approve yan."

(The Center for Drug Regulation Research evaluated it and under a CSP, it seemed compliant to FDA requirements that's why it was approved.)

Pfizer has yet to file an application for an emergency use authorization but it has signified its intension, Gutierrez said.

"Nagkakaroon na po kami ng (We have had) preliminary discussion on how they can comply with requirements of the FDA for an EUA," he said.

"December 2021 lang po ito na-approve (sa US). Expected naman po may requirements ang FDA under EUA na hindi pa po maaaring mai-submit."

(It was approved in the Us only last month, so it's expected there are FDA requirements for an EUA that it cannot yet submit.)

Paxlovid is a combination of two pills taken over five days that was shown in a clinical trial of 2,200 people to be safe and reduced the risk of hospitalizations and deaths among at-risk people by 88 percent when taken within 5 days of symptom onset.

--With a report from Agence France-Presse

Video courtesy of PTV​