MANILA, Philippines – The Philippine Food and Drug Administration (FDA) has approved the Department of Health (DOH)’s compassionate special permit (CSP) for the generic version of Pfizer’s COVID-19 antiviral pill Paxlovid.
FDA Director Oscar Gutierrez Jr. reported this to President Rodrigo Duterte during a presentation on Monday, January 10.
“Na-approve po ng FDA ang application ng DOH para sa compassionate special permit institutional use para maging accessible ang unang generic version ng paxlovid na ang brand name po ay Bexovid,” Gutierrez informed Duterte.
(The FDA has approved the application of the DOH for a compassionate special permit institutional use to make accessible the first generic version of Paxlovid with the brand name Bexovid.)
Bexovid is the word’s first generic version of the US FDA-approved brand Paxlovid made by Pfizer. Its generic name is nirmatrelvir and ritonavir.
Gutierrez said that the cost of treatment would be cheaper because Bexovid is a generic drug. The treatment will be a combination of two tablets – nirmatelvir and ritonavir – to be taken twice a day for five days.
The FDA chief said that Bexovid is made by Beximco Pharm and will be distributed in the Philippines by Biocare Lifescience.
Gutierrez said in his presentation that the treatment is said to reduce the risk of hospitalization or death by 89% if given within three days since the onset of symptoms, and by 88% if given within five days since symptoms appeared.
The approval of CSP allows the DOH to make the treatment accessible to government hospitals.
Gutierrez also said that the FDA has received two product applications for self-administered COVID-19 test kits, as the government is studying the possibility of allowing self-test kits due to the spike in infections in recent days. – Rappler.com