US FDA approves Basilea Pharmaceutica's antibiotic (updated)

Basilea Pharmaceutica AG, Allschwil

03/04/2024 20:56

(Adds details from paragraphs 2 to 4)
       April 3 (Reuters) - The U.S. health regulator approved
Basilea Pharmaceutica's  BSLN.S  antibiotic for bacterial
infections including multidrug-resistant strains, the FDA said
on Wednesday.
    The Switzerland-based company was seeking approval of its
antibiotic ceftobiprole for the treatment of three conditions -
Staphylococcus aureus bacteremia (SAB) as well as acute
bacterial skin and skin structure infections, and
community-acquired bacterial pneumonia.
        The approval expands options for patients who may have
developed a resistance to currently available antibiotics. More
than 2.8 million antimicrobial-resistant infections occur each
year in the U.S., according to the Centers for Disease Control
and Prevention.
  
       The intravenous drug, which will be sold under the brand
name Zevtera in the U.S, is an advanced-generation cephalosporin
antibiotic, and works against a wide range of Gram-positive
bacteria including methicillin-resistant strains, and
Gram-negative bacteria.
  

 (Reporting by Sriparna Roy, Unnamalai L and Christy Santhosh in
Bengaluru; Editing by Vijay Kishore)
 ((Sriparna.Roy@thomsonreuters.com;))