Drugmakers GSK and Spero Therapeutics introduced yesterday that the US Meals and Drug Administration (FDA) has permitted their investigational oral antibiotic for sophisticated urinary tract infections (cUTIs).
Marketed below the model title Utebzi, tebipenem pivoxil is the primary and solely oral carbapenem antibiotic permitted 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 remedy failure due to drug resistance.
“With antibiotic resistance persevering with to rise, sufferers and healthcare professionals want new remedy 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 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 price (a composite of medical remedy plus microbiologic eradication) was 58.5%, in contrast with 60.2% for imipenem-cilastatin, for an adjusted remedy 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 remedy 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 supplied 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 look ahead to this much-needed oral remedy possibility reaching cUTI sufferers to assist cut back the burden of the illness,” mentioned Spero Therapeutics President and CEO Esther Rajavelu, MBA.
