X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    Bispecific Cancer Drugs, Gene Therapy Advances At Next ASH

    First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

    First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

    $2 Million Gene Therapy Might Become The Standard In The US

    $2 Million Gene Therapy Might Become The Standard In The US

    Cancer Medicine Prices Jump 53% In Five Years In The U.S

    Food And Drug Administration User Fee Has Been Reauthorized

    Cancer Clinical Trials Get A Brand New Platform In Melbourne

    Report Indicates UK £62bn Behind In Global R&D Investment

    Wall Street Cautiously Optimistic After Gene Therapy Deals

    RoboCap: A Robotic Capsule to Improve Gut Drug Delivery

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    Bispecific Cancer Drugs, Gene Therapy Advances At Next ASH

    First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

    First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

    $2 Million Gene Therapy Might Become The Standard In The US

    $2 Million Gene Therapy Might Become The Standard In The US

    Cancer Medicine Prices Jump 53% In Five Years In The U.S

    Food And Drug Administration User Fee Has Been Reauthorized

    Cancer Clinical Trials Get A Brand New Platform In Melbourne

    Report Indicates UK £62bn Behind In Global R&D Investment

    Wall Street Cautiously Optimistic After Gene Therapy Deals

    RoboCap: A Robotic Capsule to Improve Gut Drug Delivery

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Drug Development FDA Approvals

FDA Approves Merck’s RECARBRIO for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia

Content Team by Content Team
8th June 2020
in FDA Approvals, Press Statements
European Commission Approves Mercks DELSTRIGO

Merck, known as MSD outside the United States and Canada, announced that the U.S. FDA has approved a supplemental New Drug Application (sNDA) for RECARBRIO for the treatment of patients 18 years of age and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible Gram-negative microorganisms: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Pseudomonas aeruginosa and Serratia marcescens. To reduce the development of drug-resistant bacteria and maintain the effectiveness of RECARBRIO and other antibacterial drugs, RECARBRIO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity to any component of RECARBRIO. See Selected Safety Information below.

“Hospital-acquired infections continue to be a significant cause of illness and death despite advances in our understanding of the contributing factors and prevention of these diseases,” said Dr. Keith Kaye, professor of medicine and director of research for the division of infectious diseases, University of Michigan Health System, and a principal investigator in the clinical program. “Because these infections are often caused by difficult to treat Gram-negative organisms, new therapeutic options such as RECARBRIO are urgently needed for patients.”

RECARBRIO is a combination of imipenem, a carbapenem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor. Relebactam protects imipenem from degradation by certain serine beta-lactamases such as SHV (Sulfhydryl Variable), TEM (Temoneira), CTX-M (Cefotaximase-Munich), P99 (Enterobacter cloacae P99), PDC (Pseudomonas-derived cephalosporinase), and KPC (Klebsiella-pneumoniae carbapenemase).

The additional indication in HABP/VABP is based on results of the pivotal Phase 3 RESTORE-IMI 2 trial that compared RECARBRIO 1.25 grams (imipenem 500 mg/cilastatin 500 mg/relebactam 250 mg) to piperacillin/tazobactam 4.5 grams (PIP/TAZ, piperacillin 4000 mg/tazobactam 500 mg), each administered intravenously every six hours for seven to 14 days, for the treatment of adult patients with HABP/VABP. RECARBRIO met the primary and key secondary endpoints, demonstrating non-inferiority to PIP/TAZ in 28-day all-cause mortality and clinical response at early follow-up, respectively. The RESTORE-IMI 2 study abstract was published by the 30th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).

“At a time of great public health concern about the need for new treatments to meet the evolving challenges posed by Gram-negative bacteria, we are proud to continue bringing new therapeutic options to health care practitioners in an effort to help them overcome the challenges in patient care,” said Dr. Nicholas Kartsonis, senior vice president, clinical research, infectious diseases and vaccines, Merck Research Laboratories. “Today’s approval is further affirmation of Merck’s steadfast commitment to meeting the needs of the health care community.”

RECARBRIO is also indicated in adults who have limited or no alternative treatment options for complicated urinary tract infections (cUTI), including pyelonephritis, and complicated intra-abdominal infections (cIAI) caused by susceptible Gram-negative bacteria, as described below. RECARBRIO is administered via intravenous injection.

About Merck

For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive bio-pharmaceutical company in the world.

Previous Post

UCB Acquires Engage Therapeutics for $125M

Next Post

AI to deliver next evolution of drug manufacturing and supply chain efficiency

Related Posts

FDA Approvals

Food And Drug Administration User Fee Has Been Reauthorized

3rd November 2022
Chinas Institute of Materia Medica Partners With Cyclica on Innovative Drug Repurposing for COVID-19
FDA Approvals

EMA Wants To Limit Immune-Regulating Medications Like FDA

31st October 2022
FDA Approvals

FDA Under Strain To Amend The Accelerated Approval Program

27th October 2022
FDA Approvals

CDC Recommends Novavax COVID Jab To Mix With Pfizer, Moderna

22nd October 2022
FDA Approvals

Rare Illness Study Will Get $38mn FDA Funding Over 4 Years

22nd October 2022
FDA Explores For Ways That Help Tailored Gene Treatment
FDA Approvals

FDA Explores For Ways That Help Tailored Gene Treatment

17th October 2022
Next Post
AI to deliver next evolution of drug manufacturing and supply chain efficiency

AI to deliver next evolution of drug manufacturing and supply chain efficiency

Latest News

Clinical Trials

Bispecific Cancer Drugs, Gene Therapy Advances At Next ASH

8th November 2022
Facilities & Operation

India Seeks Better Pharma Market Access In The UK: Official

8th November 2022
First Virtual Drug Study Tests 2 Likely Alzheimer Therapies
Clinical Trials

First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

7th November 2022
Facilities & Operation

CPhI Pharma Index Shows Unprecedented Global Pharma Optimism

5th November 2022
$2 Million Gene Therapy Might Become The Standard In The US
Drug Development

$2 Million Gene Therapy Might Become The Standard In The US

5th November 2022
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

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

Log In