Dec 11 (Reuters) – The U.S. Food and Drug Administration said on Thursday it has expanded the use of GSK’s Blujepa as an oral treatment for gonorrhea, a common sexually transmitted infection.
The health regulator approved the drug, chemically known as gepotidacin, as an oral option for the treatment of uncomplicated urogenital gonorrhea in patients 12 years of age and older who have limited or no alternative treatment options.
Gonorrhea is caused by a bacteria called neisseria gonorrhoeae that affects both men and women. If left untreated or inadequately treated, it can lead to infertility and other sexual and reproductive health complications.
There were more than 600,000 cases of gonorrhea reported in the United States in 2023 according to the US Centers for Disease Control and Prevention, making it the second most commonly reported sexually transmitted infection in the country.
It is treatable and curable with antibiotics. The current standard treatment is an injectable antibiotic.
“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.
Gepotidacin is already approved in the United States for women aged 12 years and older to treat uncomplicated UTIs, which are bacterial infections affecting the lower urinary tract.
GSK is banking on new drugs in its infectious diseases portfolio, including its recently launched respiratory syncytial virus vaccine, to make up for lost revenue from its best-selling medicines and looming patent losses for its HIV treatments.
The approval makes Blujepa the first in a new antibiotic class for the treatment of gonorrhoea approved in decades. It was based on results from a late-stage study that showed gepotidacin was not inferior to Roche’s injectable ceftriaxone and Pfizer’s oral azithromycin – a leading combination treatment regimen for gonorrhea.
(Reporting by Sneha S K and Christy Santhosh in Bengaluru; Editing by Tasim Zahid, Shailesh Kuber and Krishna Chandra Eluri)
Comments