The US FDA has approved Invanz (ertapenem), a once-daily injectable antibiotic, for the treatment of moderate to severe complicated foot infection due to indicated pathogens in diabetic patients without osteomyelitis, Merck & Co., Inc. announced here.

The approval was based on the results of the SIDESTEP study, the largest prospective, randomized and double-blind clinical trial ever conducted in diabetic patients with moderate to severe complicated foot infection. Foot infections commonly occur in patients with diabetes and are known to be difficult to treat.

"Currently there are limited data available for helping clinicians decide on the most appropriate treatment for foot infections in diabetic patients," Murray A. Abramson, medical director, Clinical Development, Infectious Diseases and Oncology at Merck said adding, "The study supporting this new indication for Invanz provides physicians with another proven option in the treatment of diabetic foot infections."

Invanz is indicated for the treatment of moderate to severe complicated skin and skin structure infections including diabetic foot infections without osteomyelitis due to Staphylococcus aureus (methicillin susceptible isolates only), Streptococcus agalactiae, Streptococcus pyogenes, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Bacteroides fragilis, Peptostreptococcus species, Porphyromonas asaccharolytica, or Prevotella bivia. INVANZ has not been studied in diabetic foot infections with concomitant osteomyelitis.

Invanz, a carbapenem related to the class of antibiotics known as beta-lactams, is also indicated for the treatment of adults and paediatric patients over three months of age for the following moderate to severe infections caused by susceptible isolates of the designated pathogens.