Tetraphase Pharmaceuticals announced that the Marketing Authorization Application for IV eravacycline has been submitted and was validated by the European Medicines Agency
- Co announced that the Marketing Authorization Application for IV eravacyclin for the treatment of complicated intra-abdominal infections has been submitted and was validated by the European Medicines Agency. Eravacycline is a novel, fully-synthetic fluorocycline antibiotic being developed for the treatment of serious infections, including those caused by multidrug-resistant pathogens.
- The MAA filing is based on data from the phase 3 IGNITE1 clinical trial in which eravacycline was well tolerated and demonstrated statistical non-inferiority to ertapenem using the primary endpoint of clinical response at the test-of-cure visit.
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