A Tetraphase Pharmaceuticals antibiotic has earned FDA approval, adding a new treatment to the effort to address drug-resistant infections.
The FDA decision for the Tetraphase (NASDAQ: TTPH) drug, eravacycline (Xerava), covers complicated intra-abdominal infections (cIAI) in adults. It’s the first drug approval for the Watertown, MA-based drug developer, and shares of the company rose 5.5 percent in after-hours trading Monday.
Gut infections can become complicated when they spread, due to a tear or other damage in the gastrointestinal tract. In two Phase 3 studies, Tetraphase tested a twice-daily infusion of its drug against ertapenem (Invanz), a now off-patent antibiotic marketed by Merck. The Tetraphase drug met the main goal of being comparable to the Merck drug in treating infection.
Tetraphase initially hoped to win FDA approval to treat complicated urinary tract (cUTI) infections, as well. But in February, the company announced eravacycline failed to match ertapenem in wiping out infections in a Phase 3 study. It was the second failure for the drug in urinary tract infections.
In the clinical studies of abdominal infections, the most common side effects were reactions at the infusion site, nausea, and vomiting. Other side effects reported for similar antibiotics include photosensitivity, high levels of nitrogen-containing compounds in the blood, and inflammation of the pancreas. Tetraphase plans to launch its new antibiotic in the U.S. in the fourth quarter this year. The drug is currently being reviewed by European regulators.
Here’s more on the origins of Tetraphase and the development of eravacycline.
Photo by Tetraphase Pharmaceuticals