Is the Paxlovid pill safe against covid-19?
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(CNN) -
Pfizer announced Tuesday that it is seeking emergency use authorization from the US Food and Drug Administration for its experimental antiviral pill against covid-19, known as PF-07321332 or Paxlovid.
"With more than 5 million deaths and countless lives affected by this devastating disease around the world, there is an urgent need for life-saving treatment options.
"The overwhelming efficacy achieved in our recent Paxlovid clinical study, and its potential to help save lives and keep people out of the hospital if licensed, underscores the critical role that oral antiviral therapies could play in the battle against COVID. -19, "Albert Bourla, Pfizer president and CEO, said in a statement.
Pfizer Signs License Agreement to Allow Wider Global Access to its Experimental Covid-19 Antiviral Pill
Pfizer claims its pill reduces risk of death 0:47
The pill must be given in combination with an older antiviral drug called ritonavir and is intended to treat mild to moderate COVID-19 in patients at increased risk of hospitalizations or death, the company says.
Earlier this month, Pfizer announced the main results of its trial saying that an interim analysis, conducted before the trial's scheduled end date, showed an 89% reduction in the risk of hospitalization or deaths from COVID-19 among women. people who received the drug within the first three days of the onset of symptoms.
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Pfizer wants the FDA to authorize booster doses for all adults
Pfizer says it is investing up to about $ 1 billion in manufacturing and distributing this treatment and also has ongoing introductions for the pill in other countries, including the UK, Australia, New Zealand and South Korea.
Merck and Ridgeback Biotherapeutics are also seeking FDA clearance for the emergency use of 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 licensed for the treatment of COVID-19 when it gained approval from the UK Medicines and Healthcare Products Regulatory Agency.
Pfizer
