The Food and Drug Administration on Tuesday approved GSK’s drug for a common type of urinary tract infection (UTI) in women and adolescent girls, one of five new approvals the British drugmaker has been expecting this year.
The antibiotic, branded as Blujepa, is approved for women aged 12 years and older to treat uncomplicated UTIs, which are bacterial infections affecting the lower urinary tract in otherwise healthy individuals.
GSK plans to launch the drug in the US in the second half of the year, and did not disclose details on pricing.
GSK is banking on new drugs in its infectious diseases portfolio, including its recently launched respiratory syncytial virus vaccine, to make up for lost revenues from its best-selling medicines and looming patent losses for its HIV treatments.
Over half of all women will experience uncomplicated UTIs in their lifetime, and around 30% will suffer at least one recurrent episode, according to GSK.
The drug chemically known as gepotidacin is designed to target the most common UTI-causing bacteria such as E. coli, the company said.
The drug acts on a different part of the bacteria compared to most other antibiotics, making it effective against organisms resistant to current treatments, according to GSK.
The bacteria is also less likely to develop resistance to the drug, as it would need to mutate in both the enzymes that gepotidacin targets, according to GSK.
Antimicrobial resistance, where bacteria withstand the drugs designed to kill them, results in over 2.8 million infections annually in the United States, according to the CDC.
The approval was based on data from two late-stage trials showing the drug was superior to nitrofurantoin, the standard-of-care medication introduced in the 1950s.
In one of GSK’s studies, gepotidacin achieved complete disease resolution in 58.5% of patients compared with 43.6% for nitrofurantoin.
The drug’s development was partly funded by multiple US government grants, GSK said.
The FDA in October last year approved another oral antibiotic, Orlynvah, developed by Irish biotech firm Iterum Therapeutics, for the treatment of certain types of bacterial UTIs in adult women.
GSK’s chief scientific officer Tony Wood said on a call ahead of the FDA approval that the drug’s method of action against the main type of bacteria causing UTIs made it competitive against Iterum’s medicine.
While GSK has not given a sales target for Blujepa, it has said it expects the medicine, along with two other medicines in development, Brexafemme and tebipenem, to generate peak year sales of more than 2 billion pounds ($2.59 billion).
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