Fierce Pharma April 4, 2024
Kevin Dunleavy

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...

Today's Sponsors

LEK
ZeOmega

Today's Sponsor

LEK

 
Topics: Biotechnology, FDA, Govt Agencies, Pharma / Biotech
FDA targets health inequality by improving at-home devices
STAT+: FDA is criticized for taking a ‘ministerial’ role in sorting out some pharma patents
We now know Tome’s gene editing target
STAT+: Pharmalittle: We’re reading about FDA dithering on pharma patents, WHO pandemic talks, and more
FDA Updates for the Week of May 6: An Approval, a Delay and Two Ad Comm Meetings

Share This Article