British regulator approves GSK’s Blujepa drug for UTI in women and girls
Britain’s medicines regulator said on Thursday it approved GSK’s (GSK.L), opens new tab Blujepa, an antibiotic pill, to treat uncomplicated urinary tract infections (UTIs) in females aged 12 and older.
The active ingredient in Blujepa, chemically known as gepotidacin, targets and blocks two enzymes that bacteria need to replicate and multiply, making it work against many drug-resistant infections such as E. coli, the Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement.
It said the approval for the oral medication is for females who weigh at least 40kg (88lbs).
GSK did not immediately respond to a Reuters request for a comment regarding the date of launch and pricing.
The U.S. Food and Drug Administration in March approved the drug, which was expected to be launched in the U.S. in the second half of this year.
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.
