FDA Approves First-in-Class GSK Antibiotic for Common Type of Urinary Tract Infection

A GSK pill that offers a lower potential for drug resistance is now FDA approved as a new treatment for a common type of urinary tract infection, the first new oral antibiotic for this indication in decades.

The regulatory decision announced Tuesday covers the treatment of female adults and pediatric patients age 12 and older who have uncomplicated urinary tract infections, or uUTIs. The drug, known in development as gepotidacin, will be marketed under the brand name Blujepa. GSK said it plans to launch the new product in the second half of this year.

Uncomplicated UTIs are infections of the bladder or urethra that develop in people who are otherwise healthy and don’t have underlying conditions. By contrast, complicated UTI is a broad term that could include those who are pregnant, immunocompromised, or have a medical condition that could lead to patients requiring more extensive treatment for the infection.

An estimated 16 million women in the U.S. develop uUTIs annually. While antibiotics are available to treat this common infection, resistance that pathogens can develop to these drugs can result in higher treatment failure rates. Blujepa, which was discovered in the labs of GSK, offers a way to address drug resistance. The drug is a small molecule designed to block two enzymes key to bacterial DNA replication. GSK said this mechanism of action is intended to provide activity against most pathogens associated with urinary tract infections, and it should also lower the potential for drug resistance.

Dosing of Blujepa is two pills taken twice daily for five days. FDA approval of Blujepa is based on the results of two Phase 3 studies that showed the therapeutic benefit from the GSK drug was not inferior to treatment with nitrofurantoin, an old antibiotic that is a standard drug therapy for uUTIs. The most common adverse events reported in the studies were gastrointestinal and included diarrhea and nausea.

“The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women,” GSK Chief Scientific Officer Tony Wood said in a prepared statement. “We are proud to have developed Blujepa, the first in a new class of oral antibiotics for uUTIs in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments.”

FDA approval of Blujepa covers five bacterial pathogens associated with UTIs. The drug also has potential in other indications. Last year, GSK reported this pill met the goals of a Phase 3 test in uncomplicated gonorrhea. Blujepa’s development was partially supported by funds from the U.S. Department of Health and Human Services among other U.S. federal funding sources.

The GSK antimicrobials pipeline includes tebipenem, a drug licensed from Spero Therapeutics now in late-stage clinical development for complicated UTIs. In 2023, GSK licensed rights to the Syncexis antifungal drug Brexafemme, which is approved for treating vaginal yeast infections. This deal also gave GSK the right to develop Brexafemme for other indications.

Photo by GSK