By Ori Twersky
WASHINGTON (Reuters Health) – Merck & Company Inc. said on Thursday that the US Food and Drug Administration has approved Invanz (ertapenem sodium), its structurally unique, once-a-day, injectable beta-lactam antibiotic.
Whitehouse, New Jersey-based Merck said that the FDA approved the once-a-day injectable formulation for moderate-to-severe adult bacterial infections caused by gram-positive and gram-negative aerobic and anaerobic bacteria.
Merck spokesperson Kyra Lindemann told Reuters Health that the pricing on the drug has yet to be determined. Lindemann added that the firm is expected to launch the antibiotic during the first quarter of 2002.
Merck is hoping to sell Invanz to hospitals as a first-line treatment for complicated intra-abdominal, skin, and skin structure infections. Lindemann told Reuters Health that the antibiotic's breadth of coverage and empirical profile combined with its ease of administration should make Invanz an ideal first-line treatment for these common infections.
But Merck cautioned that unlike other carbapenems, Invanz does not cover certain hospital-acquired pathogens such as Pseudomonas and Acinetobacter.
Merck said that the approval was based on data from 13 clinical trials that involved 1900 patients with complicated intra-abdominal infections, complicated skin and skin structure infections, community-acquired pneumonia, complicated urinary tract infections and acute pelvic infections.
Results of those clinical trials demonstrated that Invanz was equivalent to treatment with Roche Holding's Rocephin (ceftriaxone) or American Home Product's Zosyn (piperacillin/tazobactam), the company said.
Therapy with Invanz ranged from 3 to 14 days, and the primary analysis was the assessment of response to treatment at a prespecified post-therapy follow-up visit.
The most common side effects included diarrhea, infused vein complications, nausea, headache, vaginitis, vein inflammation and vomiting.
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