Tetraphase Pharmaceuticals Announces Adoption of Commission Decision Granting Marketing Authorisation Approval in the European Union for XERAVA

Tetraphase Pharmaceuticals (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today 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.

As quoted in the press release:

“The European approval of XERAVA, right after our recently announced FDA approval, marks our second significant regulatory approval within one month and reflects our commitment to bringing this novel antibiotic to patients on a global level,” said Guy Macdonald, President and Chief Executive Officer of Tetraphase. “We are excited about the approval of XERAVA in Europe, and we remain on track to launch in Europe via a phased introduction, beginning with Germany and the UK, in early 2019.”

Mr. Macdonald added, “Once again, we are grateful to the patients who have participated in our clinical studies, study investigators, physicians and our dedicated employees for bringing us to this important milestone for the Company. With the growing crisis of antibiotic resistance and the limitations of current empiric treatments for cIAI, the medical community is desperately in need of new antibiotics. Given its broad spectrum of antibacterial activity and clinical and safety profile, we believe XERAVA has the potential to address this need, and we look forward to a successful launch.”

Click here to read the full press release.