FDA grants marketing approval for Xerava

The US Food and Drug Administration has granted approval of Xerava (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI).

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, said the drug’s developer Tetraphase Pharmaceuticals (Nasdaq: TTPH).

Xerava is indicated for the treatment of complicated intra-abdominal infections in patients 18 years of age and older. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Xerava and other antibacterial drugs, Xerava should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.