Tetraphase: EC grants marketing authorization for XERAVA

Tetraphase Pharmaceuticals announced that the European Commission has adopted the Decision granting marketing authorisation for XERAVA for injection for the treatment of complicated intra-abdominal infections in adults in the European Union. In clinical trials, XERAVA 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. The European Commission approval follows the positive opinion issued by the Committee for Medicinal Products for Human Use and allows Tetraphase to market XERAVA in all countries in the European Union as well as Iceland, Liechtenstein and Norway. The decision was based on a comprehensive data package which included data from the Company’s phase 3 clinical trials investigating XERAVA in patients with cIAI compared to ertapenem and meropenem. In the first trial, twice-daily intravenous XERAVA met the primary endpoint, demonstrating non-inferiority in clinical cure versus IV ertapenem. In the second trial, twice-daily IV XERAVA met the primary endpoint, demonstrating non-inferiority in clinical cure versus IV meropenem. In both trials, XERAVA was well-tolerated and achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates.
https://thefly.com/landingPageNews.php?id=2793341