Pfizer Asks FDA To Authorize Experimental COVID-19 Antiviral Pill, Paxlovid
MIAMI (CBSMiami/CBS/CNN) -- Pfizer announced on Tuesday it is asking federal regulators to authorize its experimental antiviral COVID-19 pill.
Hours later, a source familiar with the plans said the Biden administration plans to purchase 10 million doses. The source told CNN the contract is being finalized and the announcement could come as soon as this week.
The pill is known as PF-07321332 or Paxlovid. Pfizer says it can protect people from the most severe symptoms of the disease.
"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. 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," Albert Bourla, chairman and CEO of Pfizer, said in a statement.
The pill is to be administered in combination with an older antiviral drug called ritonavir and is meant to treat mild to moderate COVID-19 in patients at increased risk of hospitalizations or death, the company says.
Earlier this month, the company said Pavlovid cut the risk of hospitalization and death by nearly 90% in people with mild to moderate coronavirus infections.
Pfizer says it is investing up to approximately $1 billion into the manufacturing and distribution of this treatment and also has rolling submissions for the pill in other countries including the UK, Australia, New Zealand and South Korea.
Merck and Ridgeback Biotherapeutics are also seeking FDA emergency use authorization an antiviral pill known as molnupiravir; an FDA advisory committee is scheduled to meet on November 30 to discuss the application.
Earlier this month, molnupiravir became the first oral antiviral to be authorized for the treatment of COVID-19 when it got signoff from the UK Medicines and Healthcare Products Regulatory Agency.
Paxlovid works similarly to remdesivir, an antiviral drug approved by the FDA last year to treat COVID-19. But the pills would be easier to administer because remdesivir must be given as an I.V. in a hospital or clinic.
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