Merck announced that the Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QDIP) with designated Fast Track status to relebactam (MK-7655) for intravenous use, in the treatment complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI), and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HAP/VAP).
Relebactam is an investigational, class A and C, beta-lactamase inhibitor that is being evaluated in combination with imipenem/cilastatin in ongoing Phase 2 clinical trials for the treatment of complicated urinary tract infections and complicated intra-abdominal infections. In preclinical studies, relebactam administered in combination with imipenem/cilastatin demonstrated antibacterial activity against a broad range of Gram-negative and beta-lactam-resistant pathogens.
Merck plans to initiate Phase 3 studies with relebactam in combination with imipenem/cilastatin in 2015.
For more information call (800) 672-6372 or visit Merck.com.