Fierce Pharma April 4, 2024
Fifteen years after Basilea’s antibiotic ceftobiprole sustained a rejection from the FDA, the company has finally won over the U.S. regulator and done so in triplicate.
The FDA has approved Basilea’s Zevtera (ceftobiprole) for three different kinds of infections. The nods will help patients who have become resistant to the current stock of available antibiotics in the U.S., most of which have been on the market for decades.
Zevtera can be administered to adults with acute bacterial skin and skin structure infections (ABSSSI) and adults with staphylococcus aureus bacteremia (SAB), a bloodstream infection that can be fatal. It also can be used on patients 3 months and older to combat community-acquired bacterial pneumonia (CABP).
The SAB approval is particularly...