One year after Fetroja approval, Shionogi expands label to include difficult-to-treat pneumonia
A year after snagging approval in complicated urinary tract infections, Shionogi’s antibiotic Fetroja has added another indication to its label: hospital-acquired and ventilator-associated bacterial pneumonia.
The FDA OK was based on Phase III data which showed the drug — chemically known as cefiderocol — was non-inferior to high-dose meropenem in all-cause mortality (ACM) after two weeks. According to the Japanese biotech, 12.4% of modified intent-to-treat patients on Fetroja died after 14 days, compared to 12.2% of patients on meropenem.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.