Relebactam Designated Qualified Infectious Disease Product Status for Complicated Infections

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.

RELATED: FDA Grants Qualified Infectious Disease Product Status to Two Anti-Infectives

Merck plans to initiate Phase 3 studies with relebactam in combination with imipenem/cilastatin in 2015.

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