Pfizer asks FDA for emergency authorization of COVID-19 pill

Officials with Pfizer on Tuesday announced that the company is asking the Food and Drug Administration to authorize emergency use of its COVID-19 pill.

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Earlier this month, Pfizer said the pill, called Paxlovid, had been shown to reduce hospitalizations or deaths from COVID-19 by up to 89% among high-risk patients.

“With more than 5 million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options,” Pfizer Chairman and CEO Albert Bourla said in a statement. “The overwhelming efficacy achieved in our recent clinical study of Paxlovid, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19.”

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He added that the company is “moving as quickly as possible ... to get this potential treatment into the hands of patients.”

Pfizer is asking the FDA to issue an Emergency Use Authorization to allow Paxlovid to be used for the treatment of high-risk patients who have mild to moderate COVID-19. If the FDA grants the request, the drug will be the first oral antiviral of its kind available, according to Pfizer.

Company officials said earlier this month that a clinical trial found Paxlovid to be highly effective when used within three to five days of the onset of symptoms of COVID-19 in high-risk patients.

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For patients who received treatment within three days of symptom onset, less than 1% remained hospitalized 28 days after beginning treatment. Meanwhile, 7% of patients who received a placebo died or remained hospitalized 28 days later, officials said. According to Pfizer, similar results were seen in patients who got the pill within five days of onset of their COVID-19 symptoms. No deaths were reported in the group that took Paxlovid.

The analysis included data from more than 1,200 people in North and South America, Europe, Africa and Asia who were enrolled in the clinical trial by Sept. 29. Participants had mild to moderate symptoms of COVID-19 and at least one characteristic or underlying medical condition that put them at higher risk of developing severe infections. As part of their treatment, they received Paxlovid or a placebo pill once every 12 hours for five days.

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Earlier this month, Bourla said trial results “suggest that our antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections and eliminate up to nine out of 10 hospitalizations.”

Officials with Merck have also asked the FDA to authorize emergency use of its antiviral COVID-19 pill, called molnupiravir.

As of Tuesday, officials have reported 47.2 million COVID-19 cases nationwide, resulting in more than 765,000 deaths, according to a tally from Johns Hopkins University. The university said 254.2 million infections have been reported globally,­ resulting in 5.1 million deaths.