The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use has recommended approval of the antibacterial eravacycline (Xerava, Tetraphase Pharmaceuticals) for treatment of adults with complicated intra-abdominal infections (cIAIs).
Eravacycline is a novel fully synthetic fluorocycline antibiotic belonging to the tetracycline group of antibiotics. It inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, thus preventing the incorporation of amino acid residues into elongating peptide chains.
Eravacycline effectively treats cIAIs, the EMA said in a press statement. The most common side effects are nausea, vomiting, and infusion site phlebitis.
Upon approval, eravacycline will be available as a 50-mg powder for concentrate for solution for infusion.
The EMA said, "Consideration should be given to official guidance on the appropriate use of antibacterial agents."
The summary of product characteristics will include detailed recommendations for use of the product and will be published in the European public assessment report, which will be made available in all official European Union languages after the European Commission grants marketing authorization.
The US Food and Drug Administration accepted a new drug application (NDA) for eravacycline earlier this year.
The NDA submission includes data from the IGNITE1 and IGNITE 4 phase 3 clinical trials, in which "twice-daily IV eravacycline was well tolerated and achieved high clinical cure rates in patients with cIAI," the company said in a statement announcing acceptance in February.
"Both studies demonstrated statistical non-inferiority of eravacycline to two widely used comparators – ertapenem in IGNITE1 and meropenem in IGNITE4 – for the primary efficacy endpoint of clinical response at the test-of-cure (TOC) visit," the company said.
Cite this: Antibacterial Eravacycline (Xerava) Gets Thumbs Up From EMA Panel - Medscape - Jul 27, 2018.