Drugmakers GSK and Spero Therapeutics introduced yesterday that the US Meals and Drug Administration (FDA) has accredited their investigational oral antibiotic for sophisticated urinary tract infections (cUTIs).
Marketed underneath the model title Utebzi, tebipenem pivoxil is the primary and solely oral carbapenem antibiotic accredited in america. The antibiotic targets cUTIs attributable to multidrug-resistant organisms, which have been sometimes handled with intravenous (IV) carbapenems.
Greater than three million cUTIs happen in america yearly, and roughly one-third of sufferers expertise therapy failure due to drug resistance.
“With antibiotic resistance persevering with to rise, sufferers and healthcare professionals want new therapy choices,” GSK Chief Scientific Officer Tony Wooden, PhD, stated in a firm press launch.
Trial knowledge present noninferiority in contrast with IV carbapenems
The FDA approval was primarily based on the outcomes of the PIVOT-PO trial, which discovered that tebipenem pivoxil was noninferior to IV imipenem-cilastatin in hospitalized sufferers with cUTI, together with pyelonephritis (kidney an infection), primarily based on the general response on the test-of-cure go to.
Tebipenem pivoxil’s total success fee (a composite of scientific remedy plus microbiologic eradication) was 58.5%, in contrast with 60.2% for imipenem-cilastatin, for an adjusted therapy distinction of –1.3%. (The noninferiority margin was –10%).
The security profile was much like that of imipenem-cilastatin and different carbapenems. The trial was stopped early for efficacy.
With antibiotic resistance persevering with to rise, sufferers and healthcare professionals want new therapy choices.
Tebipenem pivoxil was initially developed by Spero Therapeutics. In 2022, GSK signed a licensing settlement with Spero to develop and commercialize the drug in all markets besides Asia. That deal offered the financing for Spero to conduct the PIVOT-PO trial, which concerned 1,690 sufferers hospitalized with cUTIs, together with pyelonephritis.
“By means of our partnership with GSK, we stay up for this much-needed oral therapy possibility reaching cUTI sufferers to assist scale back the burden of the illness,” stated Spero Therapeutics President and CEO Esther Rajavelu, MBA.
