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GSK's Utebzi Wins FDA Nod for Complicated Urinary Tract Infections
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Key Takeaways
GSK's Utebzi won FDA approval as the first oral carbapenem for complicated UTIs in adults.
GSK's phase III study showed Utebzi was non-inferior to IV imipenem-cilastatin in patients with cUTIs.
GSK expects to launch Utebzi in the Unites States by 2026-end, adding to its growing UTI treatment portfolio.
GSK plc (GSK - Free Report) and its Cambridge-based partner, Spero Therapeutics (SPRO - Free Report) , announced that the FDA has approved tebipenem pivoxil for the treatment of complicated urinary tract infections (cUTIs). GSK will market the drug under the brand name Utebzi as the first and only oral carbapenem antibiotic for the treatment of cUTIs including pyelonephritis, in adult patients who have limited or no alternative oral treatment options. Utebzi is expected to be commercially available in the United States by the end of the year.
With Utebzi's approval, GSK further strengthens its anti-infectives portfolio, which already includes Blujepa, a first-in-class oral antibiotic approved in 2025 for the treatment of uncomplicated UTIs in women and adolescent girls aged 12 years and older. Together, these therapies expand GSK's presence across uncomplicated and complicated UTI treatment settings.
Year to date, GSK’s shares have risen 6.4% against the industry’s 1.5% decline.
Image Source: Zacks Investment Research
FDA Approves GSK’s Utebzi Based on Phase III Study
The FDA approval of Utebzi was supported by positive data from the phase III PIVOT-PO study, which demonstrated that oral Utebzi was non-inferior to intravenous imipenem-cilastatin in treating hospitalized patients with cUTIs, including pyelonephritis. At the test-of-cure visit, Utebzi achieved an overall success rate of 58.5% compared with 60.2% for imipenem-cilastatin.
cUTIs are serious urinary tract infections associated with a higher risk of complications and poorer outcomes. They commonly occur in patients with underlying conditions such as urinary tract abnormalities, kidney stones, diabetes, immune deficiencies, urinary catheters or a history of kidney transplantation. cUTIs affect more than 3 million people in the United States each year, with treatment failure occurring in up to one-third of patients.
Until now, carbapenems, the standard treatment for severe, resistant infections, were available only in intravenous form, such as Merck & Co’s (MRK - Free Report) Primaxin IV and Invanz, and Pfizer’s (PFE - Free Report) Merrem. However, Utebzi offers a convenient oral alternative that could reduce hospital dependence while improving patient care.
GSK-Spero Collaboration on Utebzi
GSK developed Utebzi in collaboration with Spero Therapeutics for the treatment of cUTIs, including pyelonephritis. The company secured exclusive rights to develop and commercialize the drug worldwide, excluding certain Asian territories, in 2022. While Spero Therapeutics continued to manage selected development activities, including the phase III PIVOT-PO study, GSK assumed responsibility for the drug’s regulatory submission and commercialization. The FDA previously granted Qualified Infectious Disease Product and Fast Track designations to Utebzi.
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Image: Bigstock
GSK's Utebzi Wins FDA Nod for Complicated Urinary Tract Infections
Key Takeaways
GSK plc (GSK - Free Report) and its Cambridge-based partner, Spero Therapeutics (SPRO - Free Report) , announced that the FDA has approved tebipenem pivoxil for the treatment of complicated urinary tract infections (cUTIs). GSK will market the drug under the brand name Utebzi as the first and only oral carbapenem antibiotic for the treatment of cUTIs including pyelonephritis, in adult patients who have limited or no alternative oral treatment options. Utebzi is expected to be commercially available in the United States by the end of the year.
With Utebzi's approval, GSK further strengthens its anti-infectives portfolio, which already includes Blujepa, a first-in-class oral antibiotic approved in 2025 for the treatment of uncomplicated UTIs in women and adolescent girls aged 12 years and older. Together, these therapies expand GSK's presence across uncomplicated and complicated UTI treatment settings.
Year to date, GSK’s shares have risen 6.4% against the industry’s 1.5% decline.
Image Source: Zacks Investment Research
FDA Approves GSK’s Utebzi Based on Phase III Study
The FDA approval of Utebzi was supported by positive data from the phase III PIVOT-PO study, which demonstrated that oral Utebzi was non-inferior to intravenous imipenem-cilastatin in treating hospitalized patients with cUTIs, including pyelonephritis. At the test-of-cure visit, Utebzi achieved an overall success rate of 58.5% compared with 60.2% for imipenem-cilastatin.
cUTIs are serious urinary tract infections associated with a higher risk of complications and poorer outcomes. They commonly occur in patients with underlying conditions such as urinary tract abnormalities, kidney stones, diabetes, immune deficiencies, urinary catheters or a history of kidney transplantation. cUTIs affect more than 3 million people in the United States each year, with treatment failure occurring in up to one-third of patients.
Until now, carbapenems, the standard treatment for severe, resistant infections, were available only in intravenous form, such as Merck & Co’s (MRK - Free Report) Primaxin IV and Invanz, and Pfizer’s (PFE - Free Report) Merrem. However, Utebzi offers a convenient oral alternative that could reduce hospital dependence while improving patient care.
GSK-Spero Collaboration on Utebzi
GSK developed Utebzi in collaboration with Spero Therapeutics for the treatment of cUTIs, including pyelonephritis. The company secured exclusive rights to develop and commercialize the drug worldwide, excluding certain Asian territories, in 2022. While Spero Therapeutics continued to manage selected development activities, including the phase III PIVOT-PO study, GSK assumed responsibility for the drug’s regulatory submission and commercialization. The FDA previously granted Qualified Infectious Disease Product and Fast Track designations to Utebzi.
GSK’s Zacks Rank
GSK currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.