Pfizer announces 89% reduction in hospitalization and mortality risk with the administration of the new corona drug Paxrovid

Pfizer, a pharmaceutical company, announces an interim report of Phase II / III clinical trials of the oral antiviral drug PAXLOVID , which is a treatment for the new coronavirus infection (COVID-19), according to COVID-19. He reported that he succeeded in reducing the risk of hospitalization or death by 89%. Pfizer says it plans to submit data to the US Food and Drug Administration (FDA) to apply for an emergency use authorization.

Pfizer's Novel COVID-19 Oral Antiviral Treatment Candidate Reduced Risk of Hospitalization or Death by 89% in Interim Analysis of Phase 2/3 EPIC-HR Study | Pfizer
https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate

UPDATE: Pfizer's oral COVID-19 antiviral cuts hospitalization, death by 85%, sending team barreling to FDA | FierceBiotech
https://www.fiercebiotech.com/biotech/pfizer-s-oral-covid-19-antiviral-cuts-hospitalization-death-by-85-sending-team-barreling-to

Paxlobide is an oral drug containing the protease inhibitor PF-07321332 and ritonavir. It is taken after being diagnosed with COVID-19 to reduce the severity rate and reduce the risk of hospitalization and death. PF-07321332 has already been developed as a treatment for COVID-19 as of April 2021 and blocks the activity of SARS-CoV-2-3CL protease, an enzyme required for the new coronavirus to self-replicate. It is a drug designed to. Ritonavir, which is compounded together, delays the metabolism or decomposition of PF-07321332, and PF-07321332 works to maintain its activity in the body for a long period of time.

According to Pfizer, the Paxrovid clinical trial was conducted in 1219 patients. Within 5 days of the onset of COVID-19, 607 patients who received Paxrovid had 6 hospitalizations and 0 deaths, whereas the control group who received placebo (placebo) had 41 hospitalizations and 10 deaths. It was a matter. Patients in the control group had an hospitalization and mortality rate of 6.7%, compared to 1% in the Paxlobide group, with an 85% reduction in risk, Pfizer reports.

In addition, the hospitalization / mortality rate of patients treated within 3 days after the onset of symptoms was 7% in the control group and 0.8% in the paxlobide-administered group, showing an 89% risk reduction. Pfizer said.

An oral antiviral drug for COVID-19 is molnupiravir, announced by Merck. Molnupiravir is similar to paxlobide in that it inhibits RNA synthesis, but with a slightly different mechanism of action. Molnupiravir has been pointed out to be mutagenic in human cells, and some have expressed concern about its safety. Pfizer reported that preclinical studies did not show mutagenicity in PF-07321332.

What is the mechanism by which the new corona drug 'Mornupiravir' works? --GIGAZINE

Pfizer emphasizes the safety of Paxlobid, saying that study discontinuation due to serious adverse events was similar to that of the control group, most of which were mild. Pfizer has data on the safety of 1881 patients at the time of the interim analysis, and is preparing to submit this data to the FDA to apply for an emergency use authorization. Merck has already submitted data on Molnupiravir to the FDA, and a meeting will be held by the FDA's advisory board on November 30, 2021.

'In terms of ease of use, Molnupiravir has an advantage over Paxrovid, and in fact it has already been approved in the United Kingdom and is being reviewed in the United States,' said science news site Fierce Biotech. Doctors may opt for Paxlobid if it outperforms the efficacy and safety of reduced illness. '

Mizuho Securities analysts said, 'In any case, global demand for oral treatment options is expected, and stockpiling of both molnupiravir and paxlobido is expected, so at least in the near future, Pfizer and Merck will have a big opportunity. I think there is. '