The FDA has approved Blujepa, the first new class of antibiotics for urinary tract infections in nearly three decades. Developed by GSK, this pill is approved for women and girls 12 and older with uncomplicated UTIs.
Blujepa belongs to a class called triazaacenaphthylenes, which target enzymes E. coli bacteria need to replicate. “This new antibiotic works its magic by using a novel binding method to block a bacteria’s ability to replicate,” said Dr. Candace Granberg of Mayo Clinic Children’s.
The approval addresses growing concerns about antimicrobial resistance. A 2019 study found resistance to at least one drug in over 92% of bacteria causing UTIs. “We absolutely need new antibiotics for uncomplicated UTIs,” Granberg noted.
In clinical trials with 3,000 participants, Blujepa successfully treated 50-58% of infections compared to 43-47% with the antibiotic nitrofurantoin.
Tony Wood, Chief Scientific Officer, GSK, said: “The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women. 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.”
UTIs affect more than half of women during their lifetime, with 30% experiencing recurring infections. If untreated, they can lead to bladder infections and kidney damage.
GSK expects Blujepa to be available in the second half of 2025. The company is also studying its effectiveness against gonorrhea.
