The P-III (ERADICATE) study evaluating ceftobiprole (IV) vs daptomycin with/out aztreonam in 390 adult patients with SAB at 50+ study centers in Eastern & Central EU & other countries
The trial met the pre-specified efficacy objective of overall success in the mITT population @70 days after randomization, a non-inferiority margin of 15%, and overall SR (69.8% vs 68.7%), was well tolerated. The company plans to submit ceftobiprole’s NDA to the US FDA at the end of 2022
The safety profile was consistent with prior P-III studies and the post-marketing with ceftobiprole, AEs were similar b/w treatment groups. If ceftobiprole is approved, it will receive 10yrs. of market exclusivity in the US from the date of approval
Ref: GlobalNewswire | Image: Basilea
