March 25 (Reuters) - The U.S. 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 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 U.S.
government grants, GSK said.
The FDA in October last year approved another oral
antibiotic, Orlynvah, developed by Irish biotech firm Iterum
Therapeutics ( ITRM ), for the treatment of certain types of bacterial
UTIs in adult women.