FDA approves new antibiotic for three different uses

The US Food and Drug Administration has approved Zevtera (ceftobiprole medocaril sodium for injection), developed by Swiss drugmaker Basilea Pharmaceutica (SIX: BSLN), whose shares were up more than 14% at 42.30 francs on the news.

Zevtera is authorized for the treatment of adults with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis; adults with acute bacterial skin and skin structure infections (ABSSSI); and adult and pediatric patients three months to less than 18 years old with community-acquired bacterial pneumonia (CABP).

David Veitch, chief executive of Basilea, said: “We are excited with the US approval of Zevtera. The positive decision by the FDA is a key milestone towards bringing Zevtera to patients in the US. Zevtera has 10 years of market exclusivity from the date of approval and we believe the US provides the most important global commercial opportunity for the brand.”