“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.”
Pharmaceutical giant Pfizer announced on Tuesday that it had asked for Emergency Use Authorization from the US Food and Drug Administration for its oral antiviral candidate that showed in clinical studies an 89% reduction in the risk of COVID-19 related hospitalization or death.
The drug, called Paxlovid, is a novel 3CL protease inhibitor antiviral therapy that the company said was designed specifically to combat the novel coronavirus, SARS-CoV-2.
“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,” Pfizer CEO Albert Bourla said in a release.
“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 US FDA on its review of our application, along with other regulatory agencies around the world,” Bourla said.
Pfizer is seeking authorization based on an interim analysis of data from its Phase II/III trial of non-hospitalized individuals over the age of 18 who had been diagnosed with COVID and were at high risk for depreciation.
The company said that will continue to gather data through ongoing studies in the United Kingdom, Australia, New Zealand and South Korea.
Paxlovid is meant to be administered in the first three to five days of symptom onset. Specifically, the data showed an 89% reduction in the risk of COVID-19 hospitalization or death from any cause in patients treated with the drug compared to a placebo.
(World Israel News).