You can now read 5 articles in a month for free on Read as much as you want anywhere and anytime for just 99¢.

Tetraphase wins FDA’s fast-track status

Tetraphase Pharmaceuticals Inc., a Watertown biotech that helped ignite a wave of initial public offerings when it went public a year ago, said Wednesday it has won fast-track designation from the Food and Drug Administration to develop an antibiotic to treat urinary tract infections.

The fast-track status is awarded to speed up the study and regulatory review of drugs that fight serious or life-threatening conditions. It will also allow Tetraphase executives to communicate more intensively with FDA regulators during the drug’s clinical trials.

Continue reading below

“We find it encouraging because it shows the FDA recognizes the product is important and addresses an unmet medical need,” said Tetraphase chief executive Guy Macdonald. He cited the rise in multidrug-resistant bacteria, calling for new antibiotics.

Macdonald said Tetraphase is on track to complete clinical trials and file a new drug application with the FDA at the end of next year.

The fast-track designation means the company would be likely to get a decision from the regulatory agency in mid-2016.

Robert Weisman can be reached at Follow him on Twitter @GlobeRobW.
Loading comments...
Want each day's news headlines delivered fresh to your
inbox every morning? Just connect with us
in one of the following ways:
Please enter a valid email will never post anything without asking.
Privacy Policy
Subscriber Log In

You have reached the limit of 5 free articles in a month

Stay informed with unlimited access to Boston’s trusted news source.

  • High-quality journalism from the region’s largest newsroom
  • Convenient access across all of your devices
  • Today’s Headlines daily newsletter
  • Subscriber-only access to exclusive offers, events, contests, eBooks, and more
  • Less than 25¢ a week
Marketing image of
Marketing image of