FDA APPROVES NEW INDICATION FOR MERCK'S INVANZ

The FDA has approved Merck's Invanz (ertapenem), a once-daily injectable antibiotic, for the prophylaxis of surgical site infection following elective colorectal surgery in adults. This approval was based upon the results of the landmark PREVENT trial, the largest prospective, randomized double-blind, comparative clinical trial ever conducted in antibiotic prophylaxis for elective colorectal surgery, according to the company.

In the PREVENT study, a randomized, double-blind, multi-center comparative trial conducted in 1,002 adult patients, 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. Invanz provides proven prophylaxis for elective colorectal surgery in a single 1-gram dose given within one hour prior to surgical incision.

Invanz, a carbapenem related to the class of antibiotics known as beta-lactams, is generally given to adults as a 1-gram dose once-a-day by intravenous infusion or intramuscular injection. In addition to the new indication, Invanz is also indicated for the treatment of adults and pediatric patients over 3 months of age for the following moderate to severe infections caused by susceptible isolates of certain pathogens.