Data from Pharmawand - Curated by EPG Health - Date added 06 February 2019
Merck Inc. announced that the FDA has accepted for review regulatory filings for Priority Review for the combination of MK 7655 + Primaxin + cilastatin (relebactam, the company’s investigational beta-lactamase inhibitor, with imipenem/cilastatin (MK-7655A, IMI/REL)), for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by certain susceptible Gram-negative bacteria, in adults with limited or no alternative therapies available.
The NDA is based on the results of the pivotal Phase III RESTORE-IMI 1 trial. The primary endpoint of the study was favorable overall response (defined by relevant endpoints for each different infection type) in the microbiological modified intent-to-treat (mMITT) population. Secondary endpoints included favorable clinical response at Day 28, 28-day all-cause mortality, incidence of treatment-emergent nephrotoxicity, and incidence of adverse events. In the study, 31 of 47 randomized and treated patients met mMITT criteria. Favorable overall response was comparable for the IMI/REL (71.4%; n=15) and COL+IMI (70.0%; n=7) treatment arms. Favorable clinical response at Day 28 was higher in the IMI/REL arm (71.4%; n=15) compared to the COL+IMI (40.0%; n=4) arm, and 28-day all-cause mortality was lower in the IMI/REL arm (9.5%; n=2) vs. COL + IMI (30.0%; n=3), respectively. Among all treated patients, drug-related adverse events occurred in 16.1% of patients (n=31) in the IMI/REL arm compared to 31.3% of patients (n=16) in the COL+IMI arm. Treatment-emergent nephrotoxicity was lower with IMI-REL (10%; 3/29 patients) compared to COL+IMI (56%; 9/16 patients) (p=0.002). The data were presented at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in Madrid, Spain, in April 2018.