On Tuesday, the Food and Drug Administration approved GSK's drugs for a common type of urinary tract infection (UTI) in women and adolescent girls.
Antibiotics branded as Blujepa are approved for women over the age of 12 and treat uncomplication UTIs, a bacterial infection that affects the lower urinary tract of other healthy individuals.
GSK is scheduled to launch the drug in the US later in the year and did not disclose pricing details.
GSK is banking new drugs with a portfolio of infectious diseases, including the recently launched respiratory endoplasmic virus vaccine.
According to GSK, more than half of all women experience uncommon UTIs in their lifetime, with about 30% going to suffer from at least one recurring episode.
According to the company, the drug chemically known as gepotidacin is designed to target bacteria that cause the most common UTIs, such as E. coli.
According to GSK, the drug acts on different parts of the bacteria compared to most other antibiotics and is effective against organisms resistant to current treatments.
According to GSK, bacteria are unlikely to develop resistance to drugs.
Antibiotic resistance that resists drugs that bacteria are designed to kill them leads to more than 2.8 million infections per year in the United States, according to the CDC.
This approval was based on data from two late trials showing that the drug was superior to Nitrofurantoin, a standard of care drug introduced in the 1950s.
In one of the GSK studies, gepothididacin achieved complete disease resolution in 58.5% of patients compared to 43.6% of nitrofluntine.
The drug's development was partially funded by multiple US government grants, GSK said.
Last October FDA Another oral antibiotic has been approvedOrlynvah, developed by Irish biotechnology company Iterum Therapeutics, was developed for the treatment of certain types of bacterial UTIs in adult women.
GSK's Chief Science Officer Tony Wood said in a call ahead of FDA approval that the method of action of the drug against the main types of bacteria that cause UTIs is competitive with Iterum's drugs.
GSK has not given Blujepa sales targets, but it says it is expected to generate more than £2 billion ($25.9 billion) peak year sales along with the other two drugs in development, along with the other drugs.





