Pharmaceutical

Tetraphase Pharmaceuticals (NASDAQ:TTPH) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave a positive opinion recommending Xerava for approval to treat adult patients with complicated intra-abdominal infections (cIAI). As quoted in the press release: The CHMP’s opinion will be reviewed by the European Commission (EC) …

Tetraphase Pharmaceuticals (NASDAQ:TTPH) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave a positive opinion recommending Xerava for approval to treat adult patients with complicated intra-abdominal infections (cIAI).

As quoted in the press release:

The CHMP’s opinion will be reviewed by the European Commission (EC) which is expected to make a final decision within three months. If approved by the EC, marketing authorization for Xerava will be granted in all 28 countries of the European Union, Norway, Iceland and Liechtenstein.

“We are highly encouraged by the CHMP’s opinion recommending Xerava for the treatment of cIAI, as it marks an exciting milestone in reaching our goal of bringing this antibiotic to patients in Europe,” said Guy Macdonald, President and Chief Executive Officer of Tetraphase Pharmaceuticals. “This is a particularly promising time for Tetraphase and Xerava. In addition to the positive CHMP opinion, we have a New Drug Application (NDA) under review by the U.S. Food and Drug Administration (FDA) with an upcoming Prescription Drug User Fee Act (PDUFA) date in August, and just last month Everest Medicines submitted an Investigational New Drug application to China’s Food and Drug Administration to conduct a phase 3 clinical trial of eravacycline in cIAI in China.”

Mr. Macdonald added, “We believe Xerava is well-positioned to be an empiric antibiotic treatment for cIAI. It also provides physicians an alternative to carbapenems and beta-lactams with beta-lactamase inhibitors. In institutions where Gram-negative resistance is a concern, we feel Xerava offers a clear advantage because it covers many MDR pathogens, which some carbapenems and beta-lactams with beta-lactamase inhibitors do not. We look forward to the continued collaboration with the EMA to complete the regulatory process in Europe.”

Click here to read the full press release.

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