Basilea Pharmaceutica has announced the submission of a new drug application (NDA) seeking approval from the US Food and Drug Administration (FDA) for its antibiotic ceftobiprole.
The NDA for ceftobiprole is intended to treat patients with acute bacterial skin and skin structure infections (ABSSSI), community-acquired bacterial pneumonia (CABP) and staphylococcus aureus bacteremia (SAB), including right-sided infective endocarditis.
Basilea’s application contains clinical safety and efficacy data from Phase III studies including ERADICATE (SAB), TARGET (ABSSSI) and a study in CABP.
Basilea anticipates an FDA decision on the application during the second quarter of 2024.
Basilea chief medical officer Dr Marc Engelhardt stated: “Staphylococcus aureus bacteremia is a common bloodstream infection with an estimated 120,000 cases in the US per year and is associated with substantial morbidity and mortality.
“Our completed Phase III programme demonstrates the efficacy of ceftobiprole in this complicated infection. The additional successfully completed Phase III studies in ABSSSI and CABP support the broad clinical utility of ceftobiprole.
Basilea has reached licence and distribution agreements for ceftobiprole in more than 80 countries.
The brand is approved and marketed under the names Zevtera and Mabelio in a number of European countries where it treats hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP) and CABP.