European Commission approves Xerava to treat cIAI infections.-Tetraphase

Tetraphase Pharmaceuticals, Inc. announced that the European Commission (EC) has adopted the Decision granting marketing authorisation for Xerava (eravacycline) for injection for the treatment of complicated intra-abdominal infections (cIAI) 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 decision was based on a comprehensive data package which included data from the Company�s phase III clinical trials investigating Xerava in patients with cIAI compared to ertapenem and meropenem. In the first trial, twice-daily intravenous (IV) 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.

Comment: Xerava will face competition from generic meropenem (~$30-150/day). However, Xerava is an option for doctors wishing to avoid overuse of meropenem, for patients intolerant of beta lactams due to allergy or impaired liver function, for patients with a history of Clostridium difficile infections or for patients where meropenem has failed..