Pfizer COVID-19 oral antiviral drug can reduce hospitalization and mortality by 89%

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Pfizer COVID-19 oral antiviral drug can reduce hospitalization and mortality by 89%

Pfizer COVID-19 oral antiviral drug can reduce hospitalization and mortality by 89%.

Pfizer’s oral COVID-19 antiviral drug combination PAXLOVID reduced the risk of hospitalization or mortality by 89% in the Phase 2/3 trial, prompting large pharmaceutical companies to stop research and race to seek emergency use authorization from the FDA.

Just a month ago, Merck’s Molnupiravir changed the rules of the game, and now it’s Pfizer’s turn. Considering the global impact of the pandemic, Pfizer has not stopped its COVID-19 vaccine.

The pharmaceutical giant continues to strengthen its “Anti-COVID-19 Armamentarium” (Anti-COVID-19 Armamentarium), and its researched oral antiviral drug candidate combination PAXLOVID (PF-07321332, Retonavir).

Recently, the company announced that in an interim analysis of the Phase 2/3 EPIC-HR study, it was found that PAXLOVID can significantly reduce hospitalization and mortality by 89%. If approved by the FDA, PAXLOVID will become the first oral antiviral drug (a specially designed SARS-CoV-2-3CL protease inhibitor).

Albert Bourla, Chairman and CEO of Pfizer, said that he believes this news is a real turnaround event in global efforts to curb the destruction of this pandemic. He strongly believes that once approved or authorized by the regulatory authorities, Pfizer’s oral antiviral drug candidates may save the lives of patients, reduce the severity of COVID-19 pneumonia infections, and eliminate up to 90% of hospitalized cases.

“Pfizer is very proud of its scientists. They designed and developed this molecule to help reduce the impact of this devastating disease on patients and their communities with the utmost sense of urgency. He expressed his appreciation to all participants in this clinical practice worldwide.

The patients, researchers and research sites of the trial are deeply grateful. Their common goal is to develop a breakthrough oral therapy to help fight the COVID-19 pneumonia,” said Dr. Mikael Dolsten, President of Pfizer Global R&D.

PAXLOVID is an investigational SARS-CoV-2 protease inhibitor antiviral therapy designed to block the activity of SARS-CoV-2-3CL protease (an enzyme that coronavirus needs to replicate). It inhibits viral replication during the proteolytic phase, which occurs before viral RNA replication.

It can be prescribed at the first sign of infection or at the first awareness of exposure, and may help patients avoid serious illness, which can lead to hospitalization and death.

After the results of the Phase 1 clinical trial were positive, Pfizer launched the EPIC-HR (COVID-19 Pneumonia Protease Inhibition Evaluation in High-risk Patients) study in July 2021. Phase 2/3 EPIC-HR is a randomized, double-blind study, the research object is COVID-19 non-hospitalized, severe (higher risk) adult patients.

Subsequently, the Phase 2/3 EPIC-SR (COVID-19 Pneumonia Protease Inhibition Evaluation in Standard Risk Patients) and EPIC-PEP (COVID-19 Pneumonia Protease Inhibition Evaluation in Post-Exposure Prevention) studies that started in August and September 2021 are not included in this In the mid-term analysis, and is in progress.

The main analysis evaluated the clinical data of 1,219 adult patients enrolled as of September 29, 2021, from clinical trial sites in North America, South America, Europe, Africa, and Asia, of which 45% of patients had data in the United States.

The selected candidates have a laboratory-confirmed diagnosis of new coronavirus infection within five days, with mild to moderate symptoms, and at least one characteristic or underlying medical condition, which is related to the increased risk of serious illness from COVID-19 pneumonia. Each patient was randomized (1:1) to take PAXLOVID or placebo orally every 12 hours for 5 consecutive days.

The scheduled interim analysis showed that compared with placebo, among patients treated within three days of the onset of symptoms, the risk of COVID-19 pneumonia-related hospitalization or death from any cause was reduced by 89% (primary endpoint); on the 28th day after randomization, 0.8% of patients who received PAXLOVID were hospitalized (3/389 people were hospitalized, no deaths), compared to 7.0% of patients who received a placebo and were hospitalized or died (27/385 were hospitalized, followed by 7 deaths). These results have high statistical significance (P<0.0001).

A similar reduction in the number of hospitalizations or deaths related to COVID-19 was observed in patients receiving treatment within five days of the onset of symptoms. In the entire study population as of the 28th day, patients who received PAXLOVID did not report deaths, while 10 patients (1.6%) who received placebo died.

Based on the recommendations of the Independent Data Monitoring Committee and in consultation with the FDA, Pfizer will stop further inclusion of the above-mentioned drugs because these results show “overwhelming efficacy.” Pfizer plans to submit the data to the FDA for emergency use authorization (EUA) rolling submission as soon as possible. At the same time, Merck’s Molnupiravir became the world’s first oral COVID-19 drug approved in the UK.

Pfizer is working hard to ensure that its new antiviral drug candidates can be used by the world’s most in need, and is waiting for successful trial results and regulatory approval. At the same time, Pfizer has also started and will continue to invest up to approximately US$1 billion to support the manufacturing and distribution of this research therapeutic drug, including exploring potential contract manufacturing options.

Pfizer COVID-19 oral antiviral drug can reduce hospitalization and mortality by 89%

(source:internet, reference only)

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