FDA approved first-class GSK antibiotics for common types of urinary tract infections
Now, the FDA is approved as a common urinary tract infection, a new treatment, a new urinary tract infection, the first new oral antibiotic for this indication in decades.
The regulatory decision announced Tuesday that it covers treatment for female adults and pediatric patients aged 12 and older whose urinary tract infection or UUTIS is not complicated. The drug (called Gepotidacin in development) will be sold under the brand Blujepa. GSK said it plans to launch new products in the second half of this year.
Simple UTIs are infections of the bladder or urethra that develop in people who are otherwise healthy and have no underlying conditions. In contrast, complex UTI is a broad term that may include pregnancy, immunocompromised persons or suffering from medical conditions that may cause patients to need a wider range of infection treatments.
An estimated 16 million women develop UUTIS each year. Although antibiotics that can be used to treat this common infection, pathogens can develop resistance to these drugs that may lead to higher rates of therapeutic failure. Blujepa, discovered in GSK laboratory, provides a solution to drug resistance. The drug is a small molecule that aims to block the replication of bacterial DNA. GSK said this mechanism of action is intended to provide activity to most pathogens associated with urinary tract infections and should also reduce the potential for drug resistance.
The dose of Blujepa is taken twice a day for five days. Blujepa's FDA approval is based on the results of a two-phase study that shows that the therapeutic benefits of GSK drugs are less than nitrofluranine treatment, an old antibiotic that is the standard drug treatment for utiS. The most common adverse events reported in the study were the gastrointestinal tract, including diarrhea and nausea.
“Blujepa's recognition is a crucial milestone among the most common infections in women,” GSK Chief Science Officer Tony Wood said in a prepared statement. “We are honored to have developed Blujepa, the first of the new oral antibiotics for UUTIS in nearly three decades and bring another option for patients and give recurrent infections and an increased resistance to existing treatments.”
FDA approved Blujepa to cover five bacterial pathogens associated with UTI. The drug also has potential in other indications. Last year, GSK reported that the pill met the goal of a simple phase 3 test for gonorrhea. Blujepa's development is partially supported by funding from the U.S. Department of Health and Human Services and other sources of federal funding.
GSK antimicrobial pipelines include Tebipenem, a drug licensed from Spero Therapeutics, currently being developed for advanced clinical development of complex UTIs. In 2023, GSK obtained permission to the Syncexis antifungal drug Brexafemme, which is approved for the treatment of vaginal yeast infections. The deal also gives GSK the right to develop Brexafemme to achieve other signs.
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