Content area
Full Text
Results of the phase 3 RESTORE-IMI 1 trial showed that relebactam was comparable to colistin when used in combination with imipenem/cilastatin in patients with drug-resistant infections, including those caused by carbapenemresistant Enterobacteriaceae. Findings also showed that the drug was associated with lower treatment-emergent nephrotoxicity.
Based on these data, Merck said it plans to submit a new drug application to the FDA for the approval of imipenem/cilastatin plus relebactam (IMI/REL). The FDA has previously designated the regimen as a qualified infectious disease product with fast track status for the treatment of hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), complicated intra-abdominal infections (cIAIs) and complicated urinary tract infections (cUTIs).
"Infections caused by gram-negative bacteria continue to be a major problem for hospitalized patients," Amanda Paschke, MD, MSCE, senior principal scientist of infectious disease clinical research at Merck, said in a press release. "The...