Basilea Pharmaceutica has received approval from the US Food and Drug Administration (FDA) for Zevtera (ceftobiprole medocaril sodium for injection) for three different indications.
The SIX Swiss Exchange-listed Basilea Pharmaceutica is a commercial-stage biopharmaceutical firm developing therapies for severe bacterial and fungal infections.
The FDA has approved the Zevtera antibiotic to treat adult patients with Staphylococcus aureus bloodstream infections (SAB), including those with right-sided infective endocarditis. Another approved indication for the antibiotic is the treatment of acute bacterial skin and skin structure infections (ABSSSI).
The third indication is for treating community-acquired bacterial pneumonia (CABP) in adults and paediatric patients between three months and 18 years.
Basilea CEO David Veitch said: “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.”
Zevtera’s new drug application (NDA) to the FDA was filed by the Swiss biopharmaceutical company in August last year.
The NDA submission was based on the clinical efficacy and safety data from the Phase 3 ERADICATE study for SAB and TARGET study for ABSSSI, and a Phase 3 trial in CABP adults.
ERADICATE assessed Zevtera`s effectiveness in treating SAB and is said to be the largest double-blind randomised registrational trial of a new antibiotic treatment in SAB.
The multicentre, double-blind, controlled trial randomised 390 patients to receive either Zevtera or daptomycin with optional aztreonam.
As per the results, the antibiotic achieved the trial’s primary efficacy endpoint of overall success. It demonstrated an overall success rate of 69.8%, compared to 68.7% in the comparator arm.
The TARGET trial assessed Zevtera’s efficacy in a similar randomised, controlled, double-blind, multinational trial with 679 subjects with ABSSSI. The antibiotic demonstrated a 91.3% early clinical response rate against 88.1% of subjects who received the comparator.
The antibiotic’s efficacy in adult CABP patients was assessed in 638 hospitalised adults.
The findings showed that 76.4% of Zevtera-administered subjects achieved clinical cure compared to 79.3% in the comparator arm.
Zevtera’s paediatric approval in CABP was supported by the data from a Phase 3 study involving 138 paediatric patients with pneumonia, aged three months to less than 18 years.
