US clears Merck & Co.'s combination antibacterial Recarbrio for urinary tract, abdominal infections

Merck & Co. announced Wednesday that the FDA has approved Recarbrio, a combination of the new beta-lactamase inhibitor relebactam with imipenem plus cilastatin, to treat adults with complicated urinary tract (cUTIs) and complicated intra-abdominal infections (cIAIs) in cases in which there are limited or no alternative treatment options. "Recarbrio provides an important addition to our toolkit in the ongoing fight against infections caused by certain Gram-negative pathogens," said Keith Kaye, a principal investigator in the clinical programme. 

According to the FDA, Recarbrio's effectiveness was determined in part by efficacy and safety findings for the previously approved antibiotic imipenem-cilastatin in treating cUTI and cIAI, while the contribution of relebactam to Recarbrio was evaluated based on data from in vitro studies and animal models of infection. The agency noted that the safety of Recarbrio, which is administered by injection, was studied in two trials, one each for cUTI and cIAI, involving 298 patients and 347 patients, respectively.

Last year, Merck reported results from the Phase III RESTORE-IMI 1 study, showing that Recarbrio was associated with a favourable overall response in the treatment of certain imipenem-non-susceptible bacterial infections, including cUTIs and cIAIs, with lower treatment-emergent nephrotoxicity, compared to a Colistin (colistimethate) plus imipenem regimen.

"The FDA remains focused on facilitating the development of safe and effective new antibacterial drugs to give patients more options to fight serious infections," stated Ed Cox, director for the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. However, he cautioned that "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."

Merck is expected to make Recarbrio, formerly MK-7655, available later this year. The therapy was previously awarded a fast-track designation by the FDA for the treatment of cUTIs, cIAIs, hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Cowen analyst Steve Scala recently estimated that relebactam will generate $50 million in revenue in 2020 and $150 million in 2024.

Meanwhile, Merck's Zerbaxa (ceftolozane/tazobactam), acquired as part of the company's $8.4-billion takeover of Cubist Pharmaceuticals in 2014, is also cleared in the US for adults with cUTIs and cIAIs. Zerbaxa's label was expanded last month to include treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in adults.   

 

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