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news.Pfizer has submitted an application to the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) of its investigational oral antiviral drug, Paxlovid (PF-07321332; ritonavir).
Paxlovid is intended to treat mild to moderate Covid-19 patients who are at higher risk of hospitalisation or death. Credit: HeungSoon from Pixabay.
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Pfizer has submitted an application to the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) of its investigational oral antiviral drug, Paxlovid (PF-07321332; ritonavir).
Paxlovid is intended to treat mild to moderate Covid-19 patients who stand at higher risk of being hospitalised or death.
PF-07321332, which can hinder the SARS-CoV-2-3CL protease activity, is given along with a low dose of ritonavir that helps to slow the metabolism or breakdown of the drug.
The company stated that the EUA submission is based on the positive data obtained from the randomised, double-blind Phase II/III EPIC-HR interim analysis.
In this trial, Covid-19 adult patients aged 18 years and above who are not hospitalised but at high risk of disease progression were enrolled.
The data showed that the treatment with Paxlovid has demonstrated an 89% decrease in Covid-19-related hospitalisation or death risk compared to placebo in patients treated within three days of symptom development.
Similar results were observed in patients treated within five days of symptom development with no deaths reported.
Pfizer chairman and CEO Albert Bourla said: “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.
“We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application, along with other regulatory agencies around the world.”
The company has commenced the rolling submissions of non-clinical data for the drug to the US FDA last month.
It has also started submissions in various countries including in the UK, South Korea, Australia, and New Zealand.
