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May 06, 2022 Post a Comment

PAXLOVID™ (PF-07321332; ritonavir) was found to reduce the run a risk of hospitalization or death past 89% compared to placebo in non-hospitalized high-take a chance adults with COVID-19
In the overall study population through 24-hour interval 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10 deaths in patients who received placebo
Pfizer plans to submit the data equally part of its ongoing rolling submission to the U.S. FDA for Emergency Utilise Authorization (EUA) as soon as possible

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced its investigational novel COVID-19 oral antiviral candidate,PAXLOVID™, significantly reduced hospitalization and death, based on an acting analysis of the Phase 2/iii EPIC-Hr ( E valuation of P rotease I nhibition for C OVID-19 in H igh- R isk Patients) randomized, double-blind study of non-hospitalized adult patients with COVID-19, who are at high risk of progressing to astringent disease. The scheduled interim analysis showed an 89% reduction in run a risk of COVID-19-related hospitalization or death from any cause compared to placebo in patients treated within 3 days of symptom onset (primary endpoint); 0.8% of patients who received PAXLOVID™ were hospitalized through Day 28 following randomization (3/389 hospitalized with no deaths), compared to seven.0% of patients who received placebo and were hospitalized or died (27/385 hospitalized with 7 subsequent deaths). The statistical significance of these results was loftier (p<0.0001). Similar reductions in COVID-19-related hospitalization or death were observed in patients treated within five days of symptom onset; 1.0% of patients who received PAXLOVID™ were hospitalized through Mean solar day 28 post-obit randomization (6/607 hospitalized, with no deaths), compared to 6.7% of patients who received a placebo (41/612 hospitalized with 10 subsequent deaths), with high statistical significance (p<0.0001). In the overall report population through Solar day 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10 (1.6%) deaths in patients who received placebo.

At the recommendation of an independent Information Monitoring Commission and in consultation with the U.S. Food and Drug Assistants (FDA), Pfizer will cease further enrollment into the study due to the overwhelming efficacy demonstrated in these results and plans to submit the data as office of its ongoing rolling submission to the U.Southward. FDA for Emergency Use Authorization (EUA) as presently as possible.

"Today'south news is a existent game-changer in the global efforts to halt the devastation of this pandemic. These data propose that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to salve patients' lives, reduce the severity of COVID-xix infections, and eliminate up to ix out of ten hospitalizations," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "Given the continued global bear on of COVID-19, we have remained laser-focused on the science and fulfilling our responsibleness to aid healthcare systems and institutions around the world while ensuring equitable and broad access to people everywhere."

If approved or authorized, PAXLOVID™, which originated in Pfizer's laboratories, would be the commencement oral antiviral of its kind, a specifically designed SARS-CoV-2-3CL protease inhibitor. Upon successful completion of the remainder of the EPIC clinical development plan and bailiwick to blessing or authorization, it could exist prescribed more broadly as an at-domicile treatment to help reduce illness severity, hospitalizations, and deaths, as well as reduce the probability of infection following exposure, among adults. It has demonstrated potent antiviral in vitro activeness against circulating variants of concern, too as other known coronaviruses, suggesting its potential as a therapeutic for multiple types of coronavirus infections.

"All of usa at Pfizer are incredibly proud of our scientists, who designed and adult this molecule, working with the utmost urgency to assistance lessen the impact of this devastating disease on patients and their communities," said Mikael Dolsten, Md, PhD., Chief Scientific Officer and President, Worldwide Inquiry, Development and Medical of Pfizer. "We're thankful to all of the patients, investigators, and sites around the earth who participated in this clinical trial, all with the common goal of bringing forth a breakthrough oral therapy to assistance combat COVID-19."

The Stage 2/three Epic-Hr written report began enrollment in July 2021. The Stage ii/iii Epic-SR ( Due east valuation of P rotease I nhibition for C OVID-19 in S tandard- R isk Patients) and Epic-PEP ( East valuation of P rotease I nhibition for C OVID-19 in P ost- Due east xposure P rophylaxis) studies, which began in August and September 2021 respectively, were not included in this acting analysis and are ongoing.

About the Phase two/iii Ballsy-Hour Study Acting Analysis

The primary assay of the interim data set evaluated data from 1219 adults who were enrolled by September 29, 2021. At the fourth dimension of the conclusion to cease recruiting patients, enrollment was at 70% of the 3,000 planned patients from clinical trial sites across Northward and South America, Europe, Africa, and Asia, with 45% of patients located in the U.s.. Enrolled individuals had a laboratory-confirmed diagnosis of SARS-CoV-2 infection within a v-day flow with mild to moderate symptoms and were required to have at least 1 characteristic or underlying medical condition associated with an increased chance of developing severe illness from COVID-19. Each patient was randomized (1:1) to receive PAXLOVID™ or placebo orally every 12 hours for 5 days.

About the Phase 2/3 EPIC-60 minutes Study Safe Data

The review of safety data included a larger cohort of 1881 patients in EPIC-HR, whose data were available at the time of the analysis. Treatment-emergent agin events were comparable between PAXLOVID™ (19%) and placebo (21%), about of which were balmy in intensity. Amid the patients evaluable for handling-emergent adverse events, fewer serious adverse events (1.7% vs. half dozen.half dozen%) and discontinuation of study drug due to agin events (two.1% vs. 4.1%) were observed in patients dosed with PAXLOVID™ compared to placebo, respectively.

About PAXLOVID™ (PF-07321332; ritonavir) and the Ballsy Development Program

PAXLOVID™ is an investigational SARS-CoV-2 protease inhibitor antiviral therapy, specifically designed to be administered orally so that it can exist prescribed at the first sign of infection or at first awareness of an exposure, potentially helping patients avert severe illness which tin can lead to hospitalization and expiry. PF-07321332 is designed to block the activity of the SARS-CoV-2-3CL protease, an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir helps wearisome the metabolism, or breakdown, of PF-07321332 in order for it to remain active in the trunk for longer periods of time at college concentrations to aid combat the virus.

PF-07321332 inhibits viral replication at a phase known every bit proteolysis, which occurs earlier viral RNA replication. In preclinical studies, PF-07321332 did not demonstrate evidence of mutagenic Dna interactions.

Pfizer initiated the Ballsy-HR report in July 2021 following positive Phase one clinical trial results and continues to evaluate the investigational antiviral in additional EPIC studies. In August 2021, Pfizer initiated the Stage two/iii Epic-SR ( E valuation of P rotease I nhibition for C OVID-xix in S tandard- R isk Patients), to evaluate efficacy and safety in patients with a confirmed diagnosis of SARS-CoV-ii infection who are at standard risk (i.e., low take chances of hospitalization or death). EPIC-SR includes a cohort of vaccinated patients who have an acute breakthrough symptomatic COVID-19 infection and who have risk factors for severe illness. In September, Pfizer initiated the Phase 2/3 Ballsy-PEP ( E valuation of P rotease I nhibition for C OVID-19 in P ost- E xposure P rophylaxis) to evaluate efficacy and safety in adults exposed to SARS-CoV-2 by a household member.

For more information on the EPIC Stage 2/3 clinical trials for PAXLOVID™, visit clinicaltrials.gov.

Nearly Pfizer's Commitment to Equitable Admission

Pfizer is committed to working toward equitable access to PAXLOVID™ for all people, aiming to deliver safe and constructive antiviral therapeutics every bit soon equally possible and at an affordable toll. If our candidate is successful, during the pandemic, Pfizer will offer our investigational oral antiviral therapy through a tiered pricing approach based on the income level of each country to promote disinterestedness of access across the earth. High and upper-middle income countries will pay more than than lower income countries. The visitor has entered into advance purchase agreements with multiple countries and is in negotiations with several others. Pfizer has likewise begun and will continue to invest up to approximately $i billion to support the manufacturing and distribution of this investigational treatment, including exploring potential contract manufacturing options to assist ensure access beyond low- and heart-income countries, pending regulatory authorization.

The company is working to ensure admission for its novel antiviral candidate for those most in need around the world, awaiting successful trial results and regulatory approval.

Near Pfizer: Breakthroughs That Change Patients' Lives

At Pfizer, we utilise science and our global resources to bring therapies to people that extend and significantly meliorate their lives. We strive to gear up the standard for quality, safety and value in the discovery, evolution and industry of health care products, including innovative medicines and vaccines. Every twenty-four hours, Pfizer colleagues work across adult and emerging markets to advance health, prevention, treatments and cures that challenge the nearly feared diseases of our time. Consequent with our responsibility equally ane of the world's premier innovative biopharmaceutical companies, nosotros collaborate with health care providers, governments and local communities to support and aggrandize access to reliable, affordable health intendance around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to larn more than, delight visit u.s. on world wide web.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Disclosure Notice

The information contained in this release is every bit of November 5, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release every bit the event of new data or future events or developments.

This release contains forwards-looking information about Pfizer's efforts to combat COVID-19 and Pfizer'southward investigational oral antiviral candidate PAXLOVID™ (including qualitative assessments of available data, potential benefits, expectations for clinical trials, advanced purchase agreements, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations, planned investment and predictable manufacturing, distribution and supply), involving substantial risks and uncertainties that could crusade actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, amid other things, the uncertainties inherent in enquiry and development, including the ability to meet anticipated clinical endpoints, outset and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, likewise as risks associated with preclinical and clinical information, including the possibility of unfavorable new preclinical, clinical or safety information and farther analyses of existing preclinical, clinical or safety data; the power to produce comparable clinical or other results including efficacy, safety and tolerability contour observed to engagement, in additional studies or in larger, more than various populations post-obit commercialization; the chance that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific customs generally, and by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from these and any time to come preclinical and clinical studies; whether and when any drug applications or submissions to request emergency utilise or conditional marketing authorization for any potential indications for PAXLOVID™ may be filed in any jurisdictions and if obtained, whether or when such emergency use say-so or licenses volition expire or terminate; whether and when regulatory authorities in whatever jurisdictions may corroborate any such applications for PAXLOVID™, which will depend on myriad factors, including making a determination as to whether the production's benefits outweigh its known risks and determination of the production'south efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safe and/or other matters that could bear upon the availability or commercial potential of PAXLOVID™, including development of products or therapies by other companies; risks related to the availability of raw materials for PAXLOVID™; the risk that we may not be able to create or scale upwardly manufacturing capacity on a timely basis or maintain admission to logistics or supply channels commensurate with global need, which would negatively impact our ability to supply the estimated numbers of courses of PAXLOVID™ inside the projected time periods; whether and when additional purchase agreements will exist reached; the risk that demand for any products may exist reduced or no longer exist; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments.

A further clarification of risks and uncertainties can be found in Pfizer'south Annual Written report on Form ten-1000 for the fiscal yr ended December 31, 2020 and in its subsequent reports on Course ten-Q, including in the sections thereof captioned "Adventure Factors" and "Forward-Looking Information and Factors That May Affect Future Results", equally well as in its subsequent reports on Form eight-K, all of which are filed with the U.S. Securities and Commutation Commission and bachelor at www.sec.gov and world wide web.pfizer.com.