FDA approves compassionate use of generic Covid-19 drug

Contributed photo
Contributed photo

THE Philippine Food and Drug Administration (FDA) has approved the compassionate special permit (CSP) of Bexovid, a more affordable drug being used to treat coronavirus disease (Covid-19), FDA director general Dr. Oscar Gutierrez said on Monday, January 10, 2022.

Gutierrez said the CSP was granted to the Department of Health (DOH).

The DOH will distribute Bexovid in government hospitals as soon as supplies arrive.

Bexovid, made by Beximco Pharm Inc., is the world's first generic version of the US FDA-approved brand Paxlovid manufactured by Pfizer. Its generic name is Nirmatrelvir and Ritonavir.

Gutierrez said the Biocare Lifescience Inc. is the main distributor of Bexovid in the Philippines.

“The treatment is given as two tablets of Nirmatrelvir and one tablet of Ritonavir together twice a day for five days. Indicated po siya for aged 12 at pataas na may mild to moderate infection,” said Gutierrez.

“Ayon sa Pfizer data, the risk of hospitalization or death is reduced by 89 percent when given within three days of symptom onset, and by 88 percent when given within five days of symptoms onset. Nakakatulong po ito para maiwasan na mapuno ang mga hospitals at ma-overwhelm po ang ating mga healthcare workers,” he added.

The FDA has so far granted emergency use authorization for the Covid-19 anti-viral drugs Casirivimab and Imdevimab or Ronapreve, and Molnupiravir or Molnarz.

Gutierrez said the application for EUA for Bexovid is already being finalized. (SunStar Philippines)

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