United States: GSK (GSK.L) obtained approval from the U.S. Food and Drug Administration to market Blujepa for treating a frequent UTI type among pre-teen girls and women. This drug approval stands among the five expected drugs, and GSK anticipates receiving FDA approval in 2023, as reported by Reuters.
Blujepa functions as a medicinal antibiotic that serves women starting at twelve years old for treating initial uncomplicated UTIs that impact the urinary tract’s lower sections in healthy adults.
The respiratory syncytial virus vaccine represents GSK’s new strategy for overcoming revenue losses from top-selling medicines along with the upcoming patent expiration of its HIV treatment medicines due to the infectious diseases drug portfolio.
A New Approach to Treating UTIs
GSK reports that UTIs affect more than 50% of women during their lives, and a third of them experience at least one recurrence.
Drug agent gepotidacin has been developed to break common UTI bacteria, including E. coli, according to the company announcement.
The drug operates at a bacteriological location that diverges from standard antibiotic processes to target treatment-resistant pathogens, according to GSK.
GSK has reported that the bacteria faces low chances of drug resistance because mutations must occur in both target enzymes to overcome gepotidacin treatment.
Acquired resistance of bacteria to medical drugs occurs frequently, leading to the estimated 2.8 million infections across the United States per year, as reported by the CDC.
Medical experts approved this treatment because clinical trial evidence demonstrated that gepotidacin provided better outcomes than nitrofurantoin. The standard-of-care antibiotic dates from the 1950s.
Superior to Standard UTI Treatments
Research conducted by GSK showed that gepotidacin produced a complete disease cure in 58.5% of patients, while nitrofurantoin succeeded only in 43.6%.
Multiple U.S. government grants funded the development process of the drug, as GSK mentioned.
FDA Expands UTI Treatment Options
Last October, the FDA approved Orlynvah as an oral medication from Iterum Therapeutics for specific bacterial urinary tract infections that impact adult women, as reported by Reuters.