Wedoany.com Report-Dec.12, The U.S. Food and Drug Administration announced on Thursday that it has approved an expanded indication for GSK's Blujepa (gepotidacin), allowing the oral antibiotic to treat uncomplicated urogenital gonorrhea in patients aged 12 years and older who have limited or no other treatment options.

Gonorrhea, caused by the bacterium Neisseria gonorrhoeae, is one of the most frequently reported sexually transmitted infections in the United States. The Centers for Disease Control and Prevention recorded more than 600,000 cases in 2023, making it the second most common notifiable STI in the country. If untreated or improperly treated, the infection can cause infertility and other reproductive health complications.

Current standard therapy consists of an injectable antibiotic. Blujepa now offers the first oral single-dose alternative in a new chemical class approved for gonorrhea in decades.

"The ability of N. gonorrhoeae to develop resistance to currently available options, including standard of care, makes it important to expand the range of effective oral treatments," said Tony Wood, chief scientific officer at GSK.

The approval rests on data from a pivotal Phase III trial demonstrating that gepotidacin was non-inferior to the combination of injectable ceftriaxone (Roche) plus oral azithromycin (Pfizer), the regimen widely used for gonorrhea.

Blujepa received its initial U.S. approval earlier for uncomplicated urinary tract infections in females aged 12 and older. The new indication broadens its role in addressing antimicrobial resistance concerns in sexually transmitted and urinary tract infections.

GSK views the infectious-disease portfolio, including Blujepa and its recently introduced respiratory syncytial virus vaccine, as a key growth driver to offset upcoming revenue declines from patent expirations on certain HIV medicines. The oral gonorrhea treatment provides a convenient option for patients and supports public-health efforts to combat rising antibiotic resistance in Neisseria gonorrhoeae.