By Pamela Cruz. Peninsula 360 Press [P360P].
Pfizer Pharmaceuticals applied Tuesday to the U.S. Food and Drug Administration (FDA) for emergency approval of its investigational oral antiviral candidate, "Paxlovid" ritonavir? Pfizer on Tuesday applied to the U.S. Food and Drug Administration (FDA) for emergency marketing authorization for its investigational oral antiviral candidate, "Paxlovid" - ritonavir - for the treatment of mild-to-moderate COVID-19 in patients at increased risk of hospitalization or death.
If approved, "Paxlovid" would be the first oral antiviral of its kind, a 3CL protease inhibitor designed specifically to combat the SARS-CoV-2 virus.
The US submission includes clinical data from an interim analysis of the Phase 2/3 EPIC-HR study, which demonstrated an 89 percent reduction in the risk of COVID-19-related hospitalization or death compared to placebo in high-risk, non-hospitalized adults with COVID-19.
Applications have begun in several countries, including the United Kingdom, Australia, New Zealand and South Korea.
"With more than 5 million deaths and countless lives affected by this devastating disease worldwide, 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 licensed, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19," said Albert Bourla, president and chief executive officer of Pfizer.
"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 in reviewing our application, along with other regulatory agencies around the world," he added.
Pfizer is seeking U.S. agency approval of Paxlovid based on positive interim analysis results from an Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients (EPIC-HR) analysis, which included non-hospitalized adults 18 years of age and older with confirmed COVID-19 who are at increased risk of progressing to severe disease.
The data demonstrated an 89 percent reduction in the risk of COVID-19-related hospitalization or death from any cause in patients treated with Paxlovid compared to placebo within three days of symptom onset, with no deaths in the treatment group.
According to Pfizer, similar results were seen within five days of symptom onset.
In a statement, the pharmaceutical company explained that the treatment-emergent adverse events were comparable between Paxlovid - 19 percent - and placebo - 21 percent - most of which were mild.
On the recommendation of an independent Data Monitoring Committee and in consultation with the FDA, Pfizer discontinued enrollment in the study due to the overwhelming efficacy demonstrated.
Pfizer announced that it has begun and will continue to invest up to approximately $1 billion of its own funds to support the manufacture and distribution of this investigational treatment candidate.
In addition, the drugmaker has signed a voluntary licensing agreement with the Medicines Patent Pool (MPP) to help expand access, pending regulatory clearance or approval, in 95 low- and middle-income countries representing approximately 53 percent of the world's population.
PAXLOVID is an investigational SARS-CoV-2 protease inhibitor antiviral therapy. It was specifically designed to be administered orally so that it can be prescribed at the first sign of infection or at the first knowledge of an exposure, potentially helping patients avoid severe illness - which can lead to hospitalization and death - experience a decrease in the symptomatic period, or avoid the development of disease after contact.
If licensed or approved, the drug is given at a dose of 300 mg - two 150 mg tablets - with one 100 mg tablet of ritonavir, twice a day for five days.
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