FDA approves 2nd drug vs COVID-19

FILE PHOTO: Facade of FDA office.

MANILA, Philippines — The Food and Drug Administration (FDA) has issued emergency use authorization (EUA) for paxlovid, making it the second antiviral drug approved to treat mild to moderate cases of COVID-19 in the country.

FDA Deputy Director General Oscar Gutierrez, the agency’s officer in charge, said at the Laging Handa briefing that paxlovid was the latest antiCOVID drug that was granted regulatory approval.

A new brand of another antiviral pill, molnupiravir, was also given an EUA last week, he said.

“I am happy to announce that we have already approved paxlovid yesterday and … another brand of molnupiravir from Bangladesh,” Gutierrez said on Friday.

An EUA is issued to unregistered drugs and vaccines in a public health emergency. But FDA earlier warned the public that an EUA is not a marketing authorization so the drug cannot be sold commercially.

Developed by pharmaceutical company Pfizer, paxlovid was designed to be administered orally so that it can be prescribed at the first sign of infection or at first awareness of an exposure. This would help high-risk patients prevent severe infection that can lead to hospitalization and death.

In November last year, Pfizer authorized generic manufacturers to supply paxlovid to low- and middle-income countries such as the Philippines through a licensing agreement.

With the latest EUA issuance, there are now two oral antiviral drugs against COVID-19. The FDA first granted EUA for Molnarz, another brand of molnupiravir produced by an Indian manufacturer, in December last year.

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