Home Editors' Picks FDA OK’s generic version of Pfizer’s pill vs coronavirus
FDA OK’s generic version of Pfizer’s pill vs coronavirus
THE LOCAL Food and Drug Administration (FDA) has approved the generic version of Pfizer, Inc.’s anti-coronavirus pill, its chief said on Monday night.
FDA Director-General Oscar G. Gutierrez, Jr. said the agency had approved the compassionate special permit application for Paxlovid, which will be sold under the brand name Bexovid.
The drug, a combination of nirmatrelvir and ritonavir, is prescribed to patients aged 12 and older who have mild to moderate infection, he said.
He added that Bexovid, which was first authorized for use in the United States, could reduce the risk of hospitalization or death by 89% when the treatment is taken within three days after symptoms occur, and 88% within five days.
Mr. Gutierrez said the drug would be available to government hospitals once the local supplier, Biocare Lifescience, Inc. starts delivery.
He said it’s up to the Health department to determine how the generic drug will be made available to patients. He said the country was still in talks with Pfizer for the emergency use authorization for the Paxlovid.
The FDA said these medicines are not a substitute for vaccines even if they can help in the fight against COVID-19.
Paxlovid could be prescribed more broadly as an at-home treatment to help reduce illness severity, hospitalizations and deaths, as well as cut the probability of infection after exposure among adults, according to Pfizer’s website.
“It has demonstrated potent antiviral in-vitro activity against circulating variants of concern, as well as other known coronaviruses, suggesting its potential as a therapeutic for multiple types of coronavirus infections,” it said.
The antiviral drug has the potential to save patients’ lives, reduce the severity of COVID-19 infections and eliminate up to nine out of 10 hospitalizations, Pfizer said in November.
“Given the continued global impact of COVID-19, we have remained laser-focused on the science and fulfilling our responsibility to help healthcare systems and institutions around the world while ensuring equitable and broad access to people everywhere.”
The US has authorized the emergency use of Pfizer’s Paxlovid and Merck’s molnupiravir and allocated for shipment to states, but the supply is tight and the rollout varies from state to state, according to the National Public Radio (NPR) website.
Right now, the drugs are just for patients at the highest risk of developing severe COVID-19 illness. People with weakened immune systems including transplant patients and older adults are especially vulnerable. Many of the hundreds of thousands of people testing positive for the coronavirus would not be candidates for the treatments, it said.
The US Department of Health and Human Services had allocated about 65,000 treatment courses of Paxlovid and 300,000 courses of molnupiravir to states and programs around the country last week, but many had not made it to their destinations, NPR said on Dec. 31.
That hasn’t stopped patients from asking for them, however. The US FDA authorized the pills for emergency use just before Christmas.
Meanwhile, the Philippine FDA was evaluating two product applications for self-administered COVID-19 test kits, Mr. Gutierrez said. The Department of Health will soon issue guidelines on their use.
Several government officials have backed the use of personal test kits as the government struggles to contain a fresh surge in infections. — Kyle Aristophere T. Atienza