Basilea Pharmaceutica Ltd, a commercial-stage biopharmaceutical company, announced positive topline results for the phase 3 ERADICATE study, evaluating ceftobiprole in the treatment of adult patients with bacterial bloodstream infections caused by Staphylococcus aureus (SAB).
Basilea is planning to submit a New Drug Application (NDA) for ceftobiprole to the US Food and Drug Administration (FDA) around year end 2022. In accordance with the agreed Special Protocol Assessment (SPA), Basilea will seek approval for SAB and acute bacterial skin and skin structure infection (ABSSSI) indications based on the successfully completed ERADICATE study and the TARGET phase 3 study, which was successfully completed in patients with ABSSSI in 2019. In addition, the company will explore the possibility for gaining approval for a third indication based on a previously performed phase 3 study in community-acquired bacterial pneumonia (CABP).
Dr. Marc Engelhardt, chief medical officer, stated:
