Pfizer seeks FDA emergency use authorization for its experimental Covid-19 antiviral pill
Posted November 16, 2021 2:05 p.m. EST
Updated November 16, 2021 2:55 p.m. EST
CNN — Pfizer announced Tuesday that it is seeking emergency use authorization from the US Food and Drug Administration for its experimental antiviral Covid-19 pill, known as PF-07321332 or 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. 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 Pfizer announced topline results from its trial saying that an interim analysis -- done before the trial was scheduled to end -- showed an 89% reduction in the risk of hospitalization or death from Covid-19 among people given the drug within the first three days of symptom onset.
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.
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