Posted by Michael Wonder on 28 Jul 2018
Tetraphase Pharmaceuticals receives positive CHMP opinion for Xerava (eravacycline) as a treatment for complicated intra-abdominal infections
27 July 2018 - Tetraphase Pharmaceuticals today announced that the CHMP of the EMA adopted a positive opinion recommending Xerava (eravacycline) for approval as a treatment for adult patients with complicated intra-abdominal infections.
The CHMP’s opinion will be reviewed by the European Commission which is expected to make a final decision within three months. If approved by the European Commission, marketing authorisation for Xerava will be granted in all 28 countries of the European Union, Norway, Iceland and Liechtenstein.
The CHMP opinion is based on a comprehensive data package from IGNITE1 and IGNITE4, which were part of the Company’s phase 3 Investigating Gram-negative Infections Treated with Eravacycline (IGNITE) program.
