Pfizer announced Tuesday that it is seeking an emergency-use authorization from the FDA for its experimental COVID-19 antiviral pill Paxlovid.
“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,” said the company Chairman and CEO Albert Bourla. “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.”
The pill is meant to target the virus in mild to moderate COVID cases in patients who are at increased risk of hospitalization or death. It is administered in combination with an antiviral drug called ritonavir.
An interim analysis of Pfizer’s trial showed an 89% reduction in the risk of hospitalization or death from COVID in patients given the drug within the first three days of symptoms beginning.
The pharmaceutical giant says it will invest about $1 billion into manufacturing and distribution efforts for the pill.
Pfizer joins Big Pharma company Merck in attempting to procure an emergency Food and Drug Administration approval for an antiviral pill to treat COVID. The application for Merck’s pill, molnupiravir, will be discussed during a Nov. 30 meeting of the FDA advisory committee.
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