Basilea Secures FDA Approval for Zevtera to Treat Three Types of Bacterial Infections

- The U.S. Food and Drug Administration (FDA) has granted approval to Basilea Pharmaceutica International Ltd.'s antibiotic Zevtera (ceftobiprole) for the treatment of three distinct types of bacterial infections.
- These include adults with acute bacterial skin and skin structure infections (ABSSSI), adults with staphylococcus aureus bacteremia (SAB), and pediatric and adult patients aged three months and above suffering from community-acquired bacterial pneumonia (CABP).
- Zevtera's efficacy in treating SAB was demonstrated in a randomized, controlled, double-blind, multinational, multicenter trial, where 69.8% of subjects receiving Zevtera achieved overall success, compared to 68.7% of subjects receiving the control group treatment.
- In the ABSSSI trial, Zevtera showed an early clinical response rate of 91.3% within 72 hours after start of treatment, compared to 88.1% in subjects receiving the control group treatment.
- For CABP patients, Zevtera demonstrated efficacy in another randomized, controlled, double-blind, multinational, multicenter trial, where the primary endpoint was met.
- The approval comes with ten years of exclusivity under the Generate Antibiotics Incentives Now (GAIN) Act as a Qualified Infectious Disease Product.
- Basilea has gained approvals for Zevtera in more than 80 countries over the last 15 years but had faced challenges obtaining FDA approval until now.