Palace welcomes FDA approval of COVID generic drug

IMMUNITY BOOSTER A boy gets vaccinated at Cainta Elementary School Auditorium in Cainta, Rizal, amid calls for an academic break as more and more households in Metro Manila get infected with COVID-19. —LYN RILLON

MANILA, Philippines — The Food and Drug Administration (FDA) has granted a compassionate special permit for the use of Bexovid, the first generic version of Pfizer’s antiviral pill Paxlovid that is expected to make the COVID-19 drug more accessible to patients.

FDA Officer in Charge Oscar Gutierrez said on Monday that the FDA approved the application of the Department of Health (DOH) for a compassionate special permit for institutional use for Bexovid.

“It is expected that the cost of treatment will be less expensive because Bexovid is a generic drug,” Gutierrez said.

According to Pfizer, Paxlovid is an antiviral drug specifically designed to be administered orally so that it can be prescribed at the first sign of infection or at first awareness of an exposure, potentially helping patients avoid severe illness that can lead to hospitalization and death.

In November last year, Pfizer authorized generic manufacturers to supply its antiviral COVID-19 pill to 95 low- and middle-income countries such as the Philippines through a licensing agreement with international public health group Medicines Patent Pool (MPP).

12 years and older

The licensing agreement between Pfizer and MPP, in turn, allowed the UN-backed group to grant sub-licenses to qualified generic drug manufacturers to make their own versions of the pill.

Gutierrez said Bexovid would be manufactured by Beximco Pharmaceuticals Ltd. (Beximco Pharma), a pharmaceutical company in Bangladesh, while Philippine-based pharmaceutical distributor Biocare Lifescience Inc. would supply the DOH with the drug.

He cited data from Pfizer showing that the drug reduced the risk of hospitalization or death by 89 percent when given within three days of symptom onset, and by 88 percent when given within five days of experiencing symptoms.

“It can help prevent hospitals from filling up and health-care workers from being overwhelmed,” he said.

It is indicated for use on people 12 years and older with mild to moderate infection, he added.

Malacañang also hailed the approval for the use of Bexovid.

“Treatment would be more affordable and could be accessed from the DOH and government hospitals,” said acting presidential spokesperson Karlo Nograles.

The approval of Bexovid comes as the Philippines registered record-high numbers of cases in the wake of the holiday rush and the detection of the highly transmissible Omicron variant.