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

For Immediate Release:

On June 5, 2020 this press release was updated with information on the data that supported its approval for this indication.

Today, the U.S. Food and Drug Administration 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, M.D., M.P.H., 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 health care 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[1] (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[2] and Priority Review[3] designations.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###



Related Information

Source URL: Read More
The public content above was dynamically discovered – by graded relevancy to this site’s keyword domain name. Such discovery was by systematic attempts to filter for “Creative Commons“ re-use licensing and/or by Press Release distributions. “Source URL” states the content’s owner and/or publisher. When possible, this site references the content above to generate its value-add, the dynamic sentimental analysis below, which allows us to research global sentiments across a multitude of topics related to this site’s specific keyword domain name. Additionally, when possible, this site references the content above to provide on-demand (multilingual) translations and/or to power its “Read Article to Me” feature, which reads the content aloud to visitors. Where applicable, this site also auto-generates a “References” section, which appends the content above by listing all mentioned links. Views expressed in the content above are solely those of the author(s). We do not endorse, offer to sell, promote, recommend, or, otherwise, make any statement about the content above. We reference the content above for your “reading” entertainment purposes only. Review “DMCA & Terms”, at the bottom of this site, for terms of your access and use as well as for applicable DMCA take-down request.

Acquire this Domain
You can acquire this site’s domain name! We have nurtured its online marketing value by systematically curating this site by the domain’s relevant keywords. Explore our content network – you can advertise on each or rent vs. buy the domain. Buy@TLDtraders.com | Skype: TLDtraders | +1 (475) BUY-NAME (289 – 6263). Thousands search by this site’s exact keyword domain name! Most are sent here because search engines often love the keyword. This domain can be your 24/7 lead generator! If you own it, you could capture a large amount of online traffic for your niche. Stop wasting money on ads. Instead, buy this domain to gain a long-term marketing asset. If you can’t afford to buy then you can rent the domain.

About Us
We are Internet Investors, Developers, and Franchisers – operating a content network of several thousand sites while federating 100+ eCommerce and SaaS startups. With our proprietary “inverted incubation” model, we leverage a portfolio of $100M in valued domains to impact online trends, traffic, and transactions. We use robotic process automation, machine learning, and other proprietary approaches to power our content network. Contact us to learn how we can help you with your online marketing and/or site maintenance.

Share

Generated by Feedzy