Melinta Therapeutics announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has adopted a positive opinion recommending Vabomere for approval as a treatment for adult patients with complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia including ventilator associated pneumonia, bacteraemia that occurs in association with any of these infections, and infections due to aerobic Gram-negative organisms where treatment options are limited. The CHMP’s opinion will be reviewed by the European Commission, or EC, which is expected to make a final decision regarding marketing authorization within 67 days of receiving the CHMP opinion. If approved by the EC, marketing authorization for Vabomere will be granted in all 28 countries of the European Union, Norway, Iceland and Liechtenstein. Milestone payment obligations related to Vabomere’s European approval would not take effect until marketing authorization is granted by the EC.
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