FDA approves generic version of Pfizer’s COVID-19 pill Paxlovid

The main office of the Food and Drugs Administration in Muntinlupa City. (Photo from the FDA Facebook page)

MANILA, Philippines — A generic version of the Paxlovid, Pfizer’s antiviral COVID-19 pill, was approved by the Philippine Food and Drug Administration (FDA), its director, Oscar Gutierrez Jr. said in a taped briefing with President Rodrigo Duterte that aired late on Monday.

“The FDA has approved the application of the DOH [Department of Health] for a compassionate special permit institutional use to make accessible the first generic version of Paxlovid with the brand name Bexovid,”z Gutierre said, speaking in a mix of English and Filipino.

“It is hoped that the cost of treatment would be cheaper because Bexovid is a generic drug,” he added.

According to Gutierrez, Bexovid is the world’s first generic counterpart of Pfizer’s Paxlovid.

The treatment will be given as two tablets — one of Nirmatelvir and one Ritonavir — together twice a day for five days.

“It’s indicated for those age 12 or older who have a mild to moderate infection,” Gutierrez said.

Citing data from Pfizer, Gutierrez said that the risk of hospitalization or death could be reduced by 89 percent when the treatment would be taken within three days of the onset of symptoms — and 88 percent within five days.

“This helps to prevent hospitals from overcrowding and overwhelming healthcare workers,” he said.

The DOH will then make the drug available to government hospitals once the country’s supplier, Biocare Lifescience Inc., has delivered its supply to the department.

“It’s up to the DOH to determine how this will be made available to the patients,” Guiterrez said.

Meanwhile, the country is still in talks with Pfizer for the emergency use authorization (EUA) of the Paxlovid antiviral drug.

But Gutierrez said that Pfizer was expected to apply for the EUA in the last week of January.

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