辉瑞寻求新型COVID-19口服药PAXLOVID的紧急使用授权

As of November 17, 2021, there are more than 570,000 confirmed cases worldwide, and more than 5 million people have died worldwide. Countless lives have been affected by this devastating disease, so new life-saving treatment options are urgently needed.

The submission to the U.S. Food and Drug Administration (FDA) includes clinical data from an interim analysis of the Phase 2/3 EPIC-HR trial, which evaluates the efficacy of protease inhibitors in high-risk COVID-19 patients. In October 2021, Pfizer began a rolling submission of non-clinical data on PAXLOVID to the US FDA.

If authorized or approved, PAXLOVID, a first-in-class oral antiviral, a 3CL protease inhibitor specifically designed to combat the SARS-CoV-2 virus, could be used as an at-home treatment in high-risk patients when they first show signs of infection, potentially helping patients avoid severe illness leading to hospitalization and death.

Pfizer's EUA for PAXLOVID is based on positive results from an interim analysis of the EPIC-HR trial, which enrolled non-hospitalized adult patients 18 years and older with confirmed COVID-19 who are at increased risk of developing severe disease. Data from the trial showed that compared with placebo, patients treated with PAXLOVID had an 89% reduction in the risk of COVID-19-related hospitalization or death from any cause within 3 days of symptom onset, with no deaths in the treatment group. Similar results were observed within 5 days of symptom onset. Treatment-emergent adverse events were comparable in the PAXLOVID group (19%) and the placebo group (21%), with the majority of them being mild. Based on the recommendation of the independent data monitoring committee and in consultation with the U.S. Food and Drug Administration, Pfizer stopped further enrollment of patients because the study had shown overwhelming efficacy. Several countries, including the UK, Australia, New Zealand and South Korea, have begun rolling submissions, with plans to submit applications to other regulators around the world.

Pfizer has begun and will continue to invest approximately $1 billion of its own capital to support the production and marketing of this investigational treatment candidate. In addition, Pfizer has signed a voluntary licensing agreement with the Medicines Patent Pool (MPP) to help expand access to 95 low- and middle-income countries (accounting for approximately 53% of the world's population), pending regulatory authorization or approval.

References:

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-seeks-emergency-use-authorization-novel-covid-19