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.
"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.