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news.Merck & Co. has said that the FDA has approved Invanz, a once-daily injectable antibiotic for surgical site infection following colorectal surgery in adults.
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This approval was based upon the results of a large comparative trial for surgical site infection (SSI) in patients who have had colorectal surgery.
“Given the high incidence of SSI, Merck is very pleased to be able to offer a new alternative with clinically demonstrated efficacy,” said Murray Abramson, senior medical director, Merck Research Labs, Infectious Diseases.
In the study, a statistically significant difference favoring Invanz over cefotetan with respect to the primary endpoint has been observed. A second adequate and well-controlled study to confirm these findings has not been conducted; therefore, the clinical superiority of ertapenem over cefotetan has not been demonstrated.
The primary endpoint in the study was the test of prophylaxis, which was defined as no evidence of SSI, post-operative anastomotic leak, or unexplained antibiotic use through four weeks post-surgery. The rates of successful prophylaxis at four weeks post-treatment in the clinically evaluable patients were 70.5% for ertapenem and 57.2% for cefotetan.