Eravacycline for intra-abdominal infectionsOctober 10, 2018
The US FDA has granted marketing authorisation to eravacycline (Xerava) for the treatment of complicated intra-abdominal infections (cIAI).
In clinical trials, eravacycline was well-tolerated and achieved high clinical cure rates in patients with cIAI, demonstrating statistical non-inferiority to two widely used comparators – ertapenem and meropenem, according to Tetraphase Pharmaceuticals, Inc.
Eravacycline is indicated for the treatment of cIAI in patients 18 years of age and older.
The antibiotic drug was investigated for the treatment of cIAI as part of IGNITE (Investigating Gram-Negative Infections Treated with Eravacycline) phase 3 programmes. In the first pivotal phase 3 trial in patients with cIAI, twice-daily intravenous (IV) eravacycline met the primary endpoint
by demonstrating statistical non-inferiority of clinical response compared to ertapenem and was well-tolerated. In the second phase 3 clinical trial in patients with cIAI, twice-daily IV eravacycline met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem and was well-tolerated. In both trials, the drug achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates, the drug maker said.