Pfizer Reports P-III Study Results of Antibiotic Aztreonam-Avibactam for Serious Bacterial Infections
Shots:
- The P-III program consists (REVISIT) study evaluating ATM-AVI ± MTZ vs MER ± COL and (ASSEMBLE) study of ATM-AVI in 422 & 15 patients with serious bacterial inf. due to gram-bacteria across 81 & 12 locations in 20 & 9 countries
- In cIAI & HAP/VAP patients, the cure rate in the ITT analysis set was (76.4% vs 74.0%) & (45.9% vs 41.7%) with a treatment difference of 2.4% & 4.3% in (REVISIT) study; cure rate (85.1% vs 79.5% & 46.7% vs 54.5%) in the CE analysis set; all-cause 28-day mortality rates (1.9% & 10.8% vs 2.9% vs 19.4%), respectively, the incidence of SAEs (19.3% vs 18.2%) & no patient experienced a treatment-related SAE
- The results from both studies are expected to form the basis for planned regulatory filings in the EU, UK, China & the US in H2’23. Pfizer holds the rights globally to commercialize ATM-AVI outside of the US & Canada
Ref: Pfizer | Image: Pfizer
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