GSK Reports the US FDA’s Approval of Blujepa (Gepotidacin) to Treat Uncomplicated Urinary Tract Infections (uUTIs)

Shots: The US FDA has approved Blujepa to treat uUTIs in female adults (≥40kg) & adolescents (≥12yrs., ≥40kg) caused by E. coli, K. pneumoniae, C. freundii complex, S. saprophyticus & E. faecalis; commercially available in H2’25 Approval was based on P-III (EAGLE-2, n=1531; EAGLE-3, n=1605) studies assessing gepotidacin (1500mg, PO, BID for 5 days) vs nitrofurantoin (100mg, PO, BID for 5 days)…

ByDipanshu DixitMarch 26, 2025

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Iterum Therapeutics’ Orlynvah (Oral Sulopenem) Receives the US FDA’s Approval to Treat uUTIs

Shots: The US FDA has approved Orlynvah (sulopenem etzadroxil & probenecid) to treat uUTIs in adult women, specifically addressing infections caused by E.coli, Klebsiella pneumoniae, or Proteus mirabilis, particularly when there are few or no other oral therapy available Approval was based on two pivotal P-III studies (SURE 1 & REASSURE) that assessed the safety…

ByDipanshu DixitOctober 25, 2024

GSK Reports the US FDA’s Approval of Blujepa (Gepotidacin) to Treat Uncomplicated Urinary Tract Infections (uUTIs)

Iterum Therapeutics’ Orlynvah (Oral Sulopenem) Receives the US FDA’s Approval to Treat uUTIs

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