FDA Gives Emergency Use Authorization To Pfizer’s Covid Treatment Pill

FDA Gives Emergency Use Authorization To Pfizer’s Covid Treatment Pill

December 29, 2021

The U.S. Food and Drug Administration on Wednesday granted Emergency Use Authorization to Pfizer’s (PFE) Covid-19 oral anti-viral pill, a breakthrough approval that experts believe will help in the battle against coronavirus.

FDA has authorized the emergency use of Paxlovid (nirmatrelvir) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

The treatment includes nirmatrelvir, which was specifically designed to block the activity of the SARS-CoV-2 Mpro, an enzyme that the coronavirus needs to replicate.

Pfizer said the pill will be made available to patients in the U.S. immediately. According to CNBC, Pfizer CEO Albert Bourla had earlier stated that the company has already shipped some of the pills to the U.S. so they can be prescribed as soon as the FDA authorization comes through.

“Today’s authorization of Paxlovid represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world. This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems,” said Bourla.

FDA’s approval was based on the final results from an analysis of all 2,246 adults enrolled in Pfizer’s phase 2/3 EPIC-HR trial of Paxlovid. The data showed Paxlovid significantly reduced the risk of hospitalization or death for any cause by 89% compared to placebo in non-hospitalized, high-risk adult patients with COVID-19 treated within three days of symptom onset.

Also, Paxlovid reduced the risk of hospitalization or death for any cause by 88% compared to placebo in patients treated within five days of symptom onset.

Paxlovid is the first oral antiviral drugs approved for emergency use by the FDA for Covid. The authorization is a blessing as the country continues to fight the onslaught of Delta variant as well as prepares for the highly contagious omicron variant.

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