Basilea Reports the NDA Submission of Ceftobiprole for the Treatment of Severe Bacterial and Fungal Infections
Shots:
- The company has submitted an NDA to the US FDA seeking approval of ceftobiprole for 3 indications - Staphylococcus aureus bacteremia (SAB), incl. right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). The US FDA decision on the NDA is expected in Q2’24
- The submission was based on the P-III studies (ERADICATE) for SAB, (TARGET) for ABSSSI, and a P-III study in CABP. The P-III program demonstrated the efficacy of ceftobiprole
- Basilea plans to commercialize ceftobiprole in the US through a partner. Ceftobiprole was approved & marketed as Zevtera and Mabelio in multiple countries in the EU for hospital-acquired bacterial pneumonia (HABP) excl. VABP & for CABP
Ref: GlobalNewswire | Image: Basilea
Related News:- Basilea Reports Results of Ceftobiprole in the P-III (ERADICATE) Study for the Treatment of Staphylococcus Aureus Bacteremia
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
