Drugmakers GSK and Spero Therapeutics introduced yesterday that the US Meals and Drug Administration (FDA) has accepted their investigational oral antibiotic for classy urinary tract infections (cUTIs).
Marketed below the model identify Utebzi, tebipenem pivoxil is the primary and solely oral carbapenem antibiotic accepted in the USA. The antibiotic targets cUTIs attributable to multidrug-resistant organisms, which have been usually handled with intravenous (IV) carbapenems.
Greater than three million cUTIs happen in the USA 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, mentioned in a firm press launch.
Trial knowledge present noninferiority in contrast with IV carbapenems
The FDA approval was based mostly 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), based mostly on the general response on the test-of-cure go to.
Tebipenem pivoxil’s general success fee (a composite of medical 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 protection profile was just 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.
“Via our partnership with GSK, we sit up for this much-needed oral therapy choice reaching cUTI sufferers to assist cut back the burden of the illness,” mentioned Spero Therapeutics President and CEO Esther Rajavelu, MBA.
