FDA approves Recarbrio for treatment of bacterial pneumonias

The US Food and Drug Administration (FDA) has approved Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) in patients 18 years of age and older.

The approval of this indication is based on limited clinical safety and efficacy data.

“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 Dr Sumathi Nambiar, 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 hospitalised 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 that is administered intravenously by a health care professional.

The safety and efficacy of Recarbrio for the treatment of HABP/VABP were evaluated in a randomised, controlled clinical trial of 535 hospitalised adults with HABP/VABP caused by gram-negative bacteria. In the trial 266 patients were treated with Recarbrio and 269 patients were treated with piperacillin-tazobactam, another antibacterial drug. Overall, 16 percent of patients who received Recarbrio and 21 percent 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), anaemia, diarrhoea, hypokalaemia (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.

This application was granted a Qualified Infectious Disease Program (QIDP) designation, given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections. Additionally, as part of QIDP designation, the FDA granted this application Fast Track and Priority Review designations.

The FDA is granting the approval to Merck & Co. Inc.