Home Pfizer Announces Paxlovid Reduces Hospitalization and Death by 89% in High-Risk COVID-19 Patients

Pfizer Announces Paxlovid Reduces Hospitalization and Death by 89% in High-Risk COVID-19 Patients

Nov 05, 2021 18:55 CST Updated 18:55
Pfizer

Pharmaceutical R&D Developer

FDA

U.S. Food and Drug Administration

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By | Jiemian Health

Just one day after Merck’s oral COVID-19 drug molnupiravir received approval in the UK, the development of oral COVID-19 therapeutics has once again been met with encouraging news.

Pfizer11Month5DayAnnouncedoneitsInvestigational oral COVID-19 drugsCandidate Drug PAXLOVIDD's latest research results show that,PAXLOVID can reduce the risk of hospitalization or death by up to 89% in non-hospitalized patients with COVID-19. Specifically, the hospitalization or death rate was only 0.8% in the treatment group (3 out of 389 patients hospitalized, with no deaths), compared to 7% in the placebo group (27 out of 385 patients hospitalized, of whom 7 subsequently died).

Pfizerindicates, asAs part of the rolling submission for Emergency Use Authorization (EUA)plan to ... as soon as possibleAforementionedData submitted to the United StatesFood and Drug Administration (FDA)。Following this news, Pfizer's US-listed shares surged in pre-market trading.10%

PAXLOVIDis a type ofProteaseInhibitorAntiviralCompoundTherapy,itsThe active ingredients are PF-07321332 and ritonavir; the former inhibits the activity of the SARS-CoV-2 3CL protease, an enzyme essential for coronavirus replication.inhibit its activityfurtherAcceptableinhibits viral replication, while ritonavirYesis an HIV medicationPfizer said,Co-administration of PF-07321332 with low-dose ritonavir helps to slow the metabolism or degradation of PF-07321332, allowing it to remain active at higher concentrations in the body for a prolonged period to help combat the virus.

Pfizer said,Becausethe aforementioned clinical trialThe results show thatOverwhelming Efficacy, based on the recommendation of the Independent Data Monitoring Committee and in consultation with the FDAPosterior, Pfizer will discontinueof the aforementioned drugfurther included in the study, with plans to submit the data as part of a rolling submission to the FDA for an Emergency Use Authorization (EUA) as soon as possible.

It is worth noting that, regarding efficacy data,PAXLOVID is considered superior to Merck’s oral COVID-19 drug molnupiravir, and can even reach the efficacy level of COVID-19 neutralizing antibody drugs.

Pfizer Chairman and Chief Executive Officer Albert BourlaIndicates:“These data indicate,theIf approved or authorized by regulatory authorities, drugs have the potential to save patients' lives and reduce`COVID-19`the severity of infection, and eliminate up to90%inpatient treatment"

Pfizer stated that ifUpon successful completion of the remainder of the clinical development program for PAXLOVID and receipt of approval or authorization,itsIt can be more widely prescribed as a home-based treatment to help reduce disease severity, hospitalization rates, and mortality, and to reduce post-exposureofInfectionPossible. In addition,In adults, PAXLOVID has demonstrated potent in vitro antiviral activity against circulating variants of concern and other known coronaviruses, indicating its potential for the treatment of multiple coronavirus infections.

Pfizerstated,PAXLOVID will be provided through a tiered pricing approach based on each country's income level to promote equitable global access. High-income and upper-middle-income countries will pay more than low-income countries.PfizerAdvance purchase agreements have been signed with multiple countries, and negotiations are ongoing with several other countries.andhas begun and will continue to invest approximately $1 billion to support the manufacturing and distribution of this investigational drug