FDA Approves Antibiotic to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia

The Food and Drug Administration (FDA) announces it has approved Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years of age and older. Recarbrio was previously FDA-approved to treat patients with complicated urinary tract infections and complicated intra-abdominal infections who have limited or no alternative treatment options.

“As a public health agency, the FDA addresses the threat of antimicrobial-resistant infections by facilitating the development of safe and effective new treatments,” said Sumathi Nambiar, MD, MPH, director of the Division of Anti-Infectives within the Office of Infectious Disease in FDA’s Center for Drug Evaluation and Research. “These efforts provide more options to fight serious bacterial infections and get new, safe and effective therapies to patients as soon as possible.”

HABP and VABP are a type of pneumonia that occurs in hospitalized patients and can cause symptoms such as fever, chills, cough, chest pain and increased oxygen requirements. Recarbrio is a combination of imipenem-cilastatin and relebactam. The drug is administered intravenously by a healthcare professional.

The safety and efficacy of Recarbrio for the treatment of HABP/VABP were evaluated in a randomized, controlled clinical trial of 535 hospitalized adults with HABP/VABP due gram-negative bacteria (a type of bacteria) in which 266 patients were treated with Recarbrio and 269 patients were treated with piperacillin-tazobactam, another antibacterial drug. Overall, 16% of patients who received Recarbrio and 21% of patients who received piperacillin-tazobactam died through Day 28 of the study.

The most common adverse reactions observed in patients treated with Recarbrio for HABP/VABP included increased aspartate/alanine aminotransferases (increased liver enzymes), anemia, diarrhea, hypokalemia (low potassium) and hyponatremia (low sodium). Before initiating therapy with Recarbrio, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams and other allergens. Recarbrio should not be used in patients who are prone to seizures and other central nervous system disorders. Clostridioides difficile-associated diarrhea has been reported with use of nearly all antibacterial agents, including Recarbrio, and may range in severity from mild diarrhea to fatal colitis.

This application was granted a Qualified Infectious Disease Program (QIDP) designation. This designation is given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. Additionally, as part of QIDP designation, the FDA granted this application Fast Track and Priority Review designations.

Source: FDA

6 Comments on "FDA Approves Antibiotic to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia"

  1. 201113 559386Hey mate, .This was an superb post for such a hard subject to talk about. I look forward to seeing numerous far more superb posts like this 1. Thanks 311107

  2. 868644 749734Aw, this became an really nice post. In thought I would like to devote writing such as this moreover – taking time and actual effort to make a extremely excellent article but exactly what do I say I procrastinate alot and by no means uncover a way to get something completed. 679639

  3. 74743 846600Hi! I just wanted to ask if you ever have any trouble with hackers? My last blog (wordpress) was hacked and I ended up losing months of hard work due to no data backup. Do you have any solutions to protect against hackers? 835005

  4. 315942 322136Excellent post. I previousally to spend alot of my time water skiing and watching sports. It was quite possible the top sequence of my past and your content material kind of reminded me of that period of my life. Cheers 221853

  5. 915168 808795Utterly composed subject material , thanks for selective info . 508754

  6. 274552 912702Hello! I merely want to make a enormous thumbs up with the fantastic info youve here during this post. We are returning to your blog for additional soon. 763537

Leave a comment

Your email address will not be published.


*