Basilea Pharmaceutica has 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鈥檚 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: 鈥淪taphylococcus 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.
鈥淥ur 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.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataBasilea 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.
