The pharmaceutical giant is asking the Food and Drug Administration (FDA) to grant authorization for Paxlovid to treat mild to moderate COVID-19 in patients at a higher risk of hospitalization and death.
Pfizer’s request makes Paxlovid the second oral COVID-19 treatment that the FDA is considering for an emergency use authorization. Merck and its partner Ridgeback Biotherapeutics submitted for authorization of molnupiravir last month.
An advisory committee plans to discuss Merck’s drug on Nov. 30.
Pfizer previously said its trial found the pills reduced the risk of hospitalizations and deaths by 89 percent. The placebo group saw 27 hospitalizations and seven deaths, while three people who received Paxlvoid were hospitalized and none died.
The treatment, which involves three pills taken twice daily for five days, is recommended within three to five days of initial symptoms for those at higher risk of severe COVID-19 due to age or underlying medical conditions.
The pill works to stop the coronavirus from multiplying using the antiviral PF-07321332 in combination with ritonavir, a drug used to treat HIV.
FDA authorization would likely help more people access a COVID-19 treatment that’s available to take at home.
Pfizer CEO Albert Bourla said in a statement that oral antiviral treatments for COVID-19, including Paxlovid, could play a “critical role” in the pandemic through preventing deaths and hospitalizations.
“We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application, along with other regulatory agencies around the world,” he said.
The request for the pill aimed to keep infected COVID-19 patients out of the hospital comes as hospitalizations appear to be stagnating in the U.S. at about 47,000 per day.
COVID-19 admissions had fallen from the summer delta surge when hospitalizations reached 103,000 per day.
Pfizer announced earlier on Tuesday that it signed an agreement to permit other manufacturers to make its antiviral pill potentially making it available to 53 percent of the world’s population.
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