Pfizer Seeks EUA for COVID-19 Antiviral Pill
- Posted by ISPE Boston
- On November 18, 2021
Pfizer is seeking Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, Paxlovid (PF-07321332; ritonavir), for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death. If authorized or approved, Paxlovid would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat SARS-CoV-2 by inhibiting viral replication at a stage known as proteolysis, which occurs before viral RNA replication. Paxlovid could be prescribed as an at-home treatment to high-risk patients at the first sign of infection, potentially helping patients avoid severe illness which can lead to hospitalization and death.
“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,” said Pfizer Chairman and CEO Albert Bourla. “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 FDA on its review of our application, along with other regulatory agencies around the world.”
Pfizer is seeking EUA for Paxlovid based on positive results from the EPIC-HR interim analysis, which enrolled non-hospitalized adults aged 18 and older with confirmed COVID-19 who are at increased risk of progressing to severe illness. The data demonstrated an 89% reduction in 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. Similar results were seen with within five days of symptom onset. At the recommendation of an independent Data Monitoring Committee, and in consultation with the FDA, Pfizer ceased further enrollment into the study due to the overwhelming efficacy demonstrated.
Pfizer has begun and will continue to invest up to approximately $1 billion of its own funds to support the manufacturing and distribution of this investigational treatment candidate. Additionally, Pfizer has signed a voluntary licensing agreement with the Medicines Patent Pool (MPP) to help expand access, pending regulatory authorization or approval, in 95 low- and middle-income countries that account for approximately 53% of the world’s population. (Source: Pfizer Website, 16 November, 2021)