“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.
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.