Pivotal Phase 3 clinical trial of oral tebipenem HBr met primary endpoint, demonstrating statistical non-inferiority versus intravenous ertapenem in patients with complicated urinary tract infection and acute pyelonephritis
Well-tolerated with comparable safety profile to intravenous ertapenem
Spero intends to complete NDA submission for U.S. regulatory approval of tebipenem HBr in the second quarter of 2021
https://finance.yahoo.com/news/speros-spro-ind-accepted-fda-141002256.html
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