The FDA has granted approval for a groundbreaking new antibiotic to treat urinary tract infections (UTIs) for the first time in almost 30 years. This innovative pill, Blujepa, developed by GSK, is now authorized for use in women and girls aged 12 and above suffering from uncomplicated UTIs, a prevalent type of infection in females often triggered by bacteria such as E. coli.
While most UTIs are typically straightforward to manage and clear up with a short course of antibiotics within a few days or weeks, the bacteria responsible are increasingly showing resistance to standard treatments, complicating the situation, as explained by Dr. Sovrin Shah, an associate professor of urology at Mount Sinai Hospital in New York. The rise of antimicrobial-resistant infections in the U.S., totaling over 2.8 million cases annually, underscores the urgent need for new antibiotics, given that over 92% of bacteria causing UTIs were found to be resistant to at least one drug in a 2019 study, with approximately 80% showing resistance to at least two.
Introducing novel antibiotics that combat bacteria in different ways is crucial in combating drug resistance and preserving treatment options open, emphasized Dr. Candace Granberg, a pediatric urologist and surgeon-in-chief at Mayo Clinic Children’s in Rochester, Minnesota. The symptoms of UTIs, which may include a burning sensation during urination, blood in urine, frequent urination, and a strong urge to urinate, if left untreated, can lead to severe complications like bladder infections and kidney damage.
Blujepa, a part of a fresh class of antibiotics known as triazaacenaphthylenes, operates by targeting two essential enzymes required by E. coli bacteria for replication and survival. This new antibiotic prevents bacterial replication by utilizing a unique binding method to impede their ability to multiply, according to Granberg.
GSK disclosed that the last time a new class of antibiotics was approved by the FDA for uncomplicated UTIs was in 1996 with fosfomycin, with the recent approval of Pivya for UTIs occurring last year, belonging to the penicillin drug category. Clinical trials involving 3,000 adults and adolescents in two phase 3 studies demonstrated that Blujepa effectively treated 50% to 58% of infections when taken twice daily for five days, surpassing the efficacy of the antibiotic nitrofurantoin, which treated infections in 43% to 47% of cases.
As per a 2019 report, more than half of women will experience at least one UTI in their lifetime, with around 30% encountering recurring infections. GSK is exploring whether Blujepa can also combat gonorrhea, as noted by Tony Wood, the company’s chief scientific officer.
