FDA Approves New Antibacterial Combination for Treating Certain Infections in Adults

The FDA has approved Merck’s antibacterial drug injection—a combination of imipenem, cilastatin and relebactam (Recarbrio) —for treating adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).^1,2

“The FDA remains focused on facilitating the development of safe and effective new antibacterial drugs to give patients more options to fight serious infections,” said Ed Cox, MD, MPH, director for the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research, in a prepared statement.¹ “It is important that the use of Recarbrio be reserved for situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection.”

Imipenem-cilastatin is a previously FDA-approved antibiotic.¹ Imipenem is a penem antibacterial drug, and cilastatin sodium is a renal dehydropeptidase inhibitor. Cilastatin limits the renal metabolism of imipenem and does not have antibacterial activity.² Relebactam is a new beta-lactamase inhibitor.^1,2

The determination of efficacy of the 3-drug combination was supported in part by the findings of the efficacy and safety of imipenem-cilastatin for the treatment of cUTI and cIAI. The contribution of relebactam to the new product was assessed based on data from in vitro studies and animal models of infection.¹

The safety of the 3-drug injection was studied in 2 trials, 1 each for cUTI and cIAI. The cUTI trial included 298 adult patients with 99 treated with the proposed dose of the 3-drug injection. The cIAI trial included 347 patients with 117 treated with the proposed dose of this new product.^1,2

“Recarbrio provides an important addition to our toolkit in the ongoing fight against infections caused by certain Gram-negative pathogens,” said Dr Keith Kaye, professor of medicine and director of research for the division of infectious diseases, University of Michigan Heath System, and a principal investigator in the clinical program, in a prepared statement.² “Recarbrio offers an additional treatment option for patients with cIAI and cUTI who have limited and, in some cases, no alternative therapeutic options.”

The most common adverse reactions observed in patients treated with the 3-drug combination included nausea, diarrhea, headache, fever and increased liver enzymes.^1,2

Merck received the FDA’s Qualified Infectious Disease Product (QIDP) designation for its new product. The QIDP 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. As part of QIDP designation, the 3-drug combination also was granted Priority Review.^1,2

References

• FDA approves new treatment for complicated urinary tract and complicated intra-abdominal infections [news release]. Silver Spring, MD; July 17, 2019: FDA website. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-complicated-urinary-tract-and-complicated-intra-abdominal-infections. Accessed July 17, 2019.
• FDA Approves Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) For the Treatment of Adults with Complicated Urinary Tract and Complicated Intra-Abdominal Bacterial Infections Where Limited or No Alternative Treatment Options Are Available [news release]. Kenilworth, NJ; July 17, 2019: Merck. https://www.mrknewsroom.com/news-release/prescription-medicine-news/fda-approves-mercks-recarbrio-imipenem-cilastatin-and-releba. Accessed July 17, 2019.