Merck Reports Results of Recarbrio (imipenem/cilastatin/relebactam) in P-III RESTORE-IMI 2 Study for Patients with HABP/VABP
Merck’s Recarbrio (imipenem/cilastatin/relebactam) Receives the US FDA’s Approval for Complicated Urinary Tract and Complicated Intra-Abdominal Bacterial Infections
Shots:
- The P-III RESTORE-IMI 2 study involves assessing of Recarbrio (imipenem 500 mg, cilastatin 500 mg, and relebactam 250 mg) vs Piperacillin/Tazobactam in adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP)
- The P-III RESTORE-IMI 2 study resulted in meeting its 1EPs & 2EPs of statistical non-inferiority in Day 28 all-cause mortality and clinical response at early follow-up, respectively
- Recarbio (IV) is a combination of penem antibacterial drug, renal dehydropeptidase inhibitor & beta-lactamase inhibitor, its component Relebactam has received FDA’s QIDP, Fast Track designation for HABP/VABP
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