Shots:
- The US FDA has approved Zevtera to treat adult patients with SAB infections such as right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSI) as well as community-acquired bacterial pneumonia (CABP) in adult & pediatric patients (3mos. to <18yrs.)
- The NDA was based on efficacy & safety results from P-III trials incl. ERADICATE (for SAB), TARGET (for ABSSSI) & a P-III trial for CABP
- Additionally, Basilea was awarded ~$112M from US HHS, ASPR & BARDA for the P-III study of Zevtera, covering ~75% cost of SAB & ABSSSI studies, regulatory efforts & non-clinical work
Ref: PRNewswire | Image: Basilea | Press Release
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