Tuesday, January 31, 2023
  • Login
CEO North America
  • Home
  • Business
    • Entrepreneur
    • Industry
    • Innovation
    • Management & Leadership
  • CEO Interviews
  • CEO Life
    • Art & Culture
    • Food
    • Health
    • Travel
    • Environment
  • Opinion
  • News
  • Multimedia
No Result
View All Result
  • Home
  • Business
    • Entrepreneur
    • Industry
    • Innovation
    • Management & Leadership
  • CEO Interviews
  • CEO Life
    • Art & Culture
    • Food
    • Health
    • Travel
    • Environment
  • Opinion
  • News
  • Multimedia
No Result
View All Result
CEO North America
No Result
View All Result

Pfizer Seeks Emergency Use Authorization for Novel Covid-19 Oral Antiviral Candidate

in Health
Pfizer seeks emergency use authorization for novel covid-19 oral antiviral candidate
Share on FacebookShare on Twitter

Pfizer Inc. this Tuesday  announced it is seeking Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, PAXLOVID™ (PF-07321332; ritonavir), for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death. This submission to the U.S. Food and Drug Administration (FDA) includes clinical data from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) interim analysis. Rolling submission of non-clinical data for PAXLOVID was initiated with the U.S. FDA in October 2021.

If authorized or approved, PAXLOVID would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat SARS-CoV-2 that could be prescribed as an at-home treatment to high-risk patients at the first sign of infection, potentially helping patients avoid severe illness which can lead to hospitalization and death.

“With more than 5 million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options. The overwhelming efficacy achieved in our recent clinical study of PAXLOVID, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application, along with other regulatory agencies around the world.”

Pfizer is seeking EUA for PAXLOVID based on positive results from the EPIC-HR interim analysis, which enrolled non-hospitalized adults aged 18 and older with confirmed COVID-19 who are at increased risk of progressing to severe illness. The data demonstrated an 89% reduction in risk of COVID-19-related hospitalization or death from any cause in patients treated with PAXLOVID compared to placebo within three days of symptom onset, with no deaths in the treatment group. Similar results were seen with within five days of symptom onset. Treatment-emergent adverse events were comparable between PAXLOVID (19%) and placebo (21%), most of which were mild in intensity.

At the recommendation of an independent Data Monitoring Committee, and in consultation with the U.S. FDA, Pfizer ceased further enrollment into the study due to the overwhelming efficacy demonstrated. Rolling submissions have commenced in several countries including in the United Kingdom, Australia, New Zealand and South Korea, with planned submissions to other regulatory agencies around the world to follow.

Pfizer has begun and will continue to invest up to approximately $1 billion of its own funds to support the manufacturing and distribution of this investigational treatment candidate. Additionally, Pfizer has signed a voluntary licensing agreement with the Medicines Patent Pool (MPP) to help expand access, pending regulatory authorization or approval, in 95 low- and middle-income countries that account for approximately 53% of the world’s population.

If authorized or approved, PAXLOVID will be administered at a dose of 300mg (two 150mg tablets) of PF-07321332 with one 100mg tablet of ritonavir, given twice-daily for five days.

(courtesy Pfizer)

Tags: COVID-19Emergency Use AuthorizationOral Antiviral CandidatePfizer

Related Posts

Fast food fans may face liver damage
Health

Fast food fans may face liver damage

Can the ai driving chatgpt help to detect early signs of alzheimer’s disease?
Health

Can the AI driving ChatGPT help to detect early signs of Alzheimer’s disease?

Are our brains wired to quiet quit?
Health

Are our brains wired to quiet quit?

New research indicates that weak muscles may speed up aging
Health

New research indicates that weak muscles may speed up aging

Fatigue might not mean you’re tired – 5 major causes and solutions
Health

Fatigue Might Not Mean You’re Tired – 5 Major Causes and Solutions

Drink water, live longer? Study finds link between hydration and aging
Health

Drink water, live longer? Study finds link between hydration and aging

Researchers use 3d bioprinting to create eye tissue
Health

Researchers use 3D bioprinting to create eye tissue

- what we know and don't know about the xbb. 1. 5 covid subvariant
Health

What we know and don’t know about the XBB.1.5 COVID subvariant

The biggest health trends of 2023
Health

The biggest health trends of 2023

The relationship between employee engagement and mental health
Health

The Relationship Between Employee Engagement and Mental Health

No Result
View All Result

Recent Posts

  • Payments firm PayPal to lay off 7% of its workforce to cut costs
  • Apple workplace rules violate U.S. labor law, agency finds
  • Helping Gen Z Employees Find Their Place at Work
  • Why Your Talent Team Needs Scenario Planning
  • Walmart, CVS Health adjust pharmacy hours due to labor crunch

Recent Comments

    Archives

    Categories

    • Art & Culture
    • Business
    • CEO Interviews
    • CEO Life
    • Editor´s Choice
    • Entrepreneur
    • Environment
    • Food
    • Health
    • Highlights
    • Industry
    • Innovation
    • Issues
    • Management & Leadership
    • Multimedia
    • News
    • Opinion
    • PrimeZone
    • Printed Version
    • Travel
    • Uncategorized

    Meta

    • Log in
    • Entries feed
    • Comments feed
    • WordPress.org

    • CONTACT
    • GENERAL ENQUIRIES
    • ADVERTISING
    • MEDIA KIT
    • DIRECTORY
    • TERMS AND CONDITIONS

    Editorials – stuart.james@ceo-na.com

    Editor-In-Chief – caroline.sposto@ceo-na.com

    Editorials – editorials@ceo-na.com

    Advertising – media@ceo-na.com

    NEW YORK

    110 Wall St.,
    3rd Floor
    New York, NY.
    10005
    USA
    +1 212 432 5800

     

    MEXICO CITY

    Paseo de la Reforma 296,
    Floor 38
    Mexico City
    06600
    MEXICO

    • CONTACT
    • GENERAL ENQUIRIES
    • ADVERTISING
    • MEDIA KIT
    • DIRECTORY
    • TERMS AND CONDITIONS

    Editorials –
    stuart.james@ceo-na.com

    Editor-In-Chief –

    caroline.sposto@ceo-na.com

    Editorials – editorials@ceo-na.com

    Advertising –
    media@ceo-na.com

    NEW YORK

    110 Wall St.,
    3rd Floor
    New York, NY.
    10005
    USA
    +1 212 432 5800

    MEXICO CITY

    Paseo de la Reforma 296,
    Floor 38
    Mexico City
    06600
    MEXICO

    CEO North America © 2022 - Sitemap

    No Result
    View All Result
    • Home
    • Business
      • Entrepreneur
      • Industry
      • Innovation
      • Management & Leadership
    • CEO Interviews
    • CEO Life
      • Art & Culture
      • Food
      • Health
      • Travel
      • Environment
    • Opinion
    • News
    • Multimedia

    © 2023 JNews - Premium WordPress news & magazine theme by Jegtheme.

    Welcome Back!

    Login to your account below

    Forgotten Password?

    Retrieve your password

    Please enter your username or email address to reset your password.

    Log In