The Food and Drug Administration on Tuesday approved the first drug in a new class of antibiotics for treating urinary tract infections — the first time that’s happened in nearly 30 years.
The drug, a pill called Blujepa from drugmaker GSK, was approved for women and girls 12 and up with uncomplicated UTIs — the most common type of the infection in women, often caused by bacteria including E. coli.
Most UTIs are easy to treat, usually clearing up within a few days or weeks after a short course of antibiotics.
But the bacteria that commonly cause them are increasingly becoming resistant to the standard antibiotics, making treatment more difficult, said Dr. Sovrin Shah, an associate professor of urology at Mount Sinai Hospital in New York.
More than 2.8 million antimicrobial-resistant infections occur in the U.S. each year, according to the Centers for Disease Control and Prevention. A 2019 study found resistance to at least one drug in more than 92% of bacteria that can cause UTIs. Around 80% showed resistance to at least two.
Developing new antibiotics that attack bacteria in different ways reduces the risk of drug resistance, helping to keep treatment options open, said Dr. Candace Granberg, a pediatric urologist and surgeon-in-chief at Mayo Clinic Children’s in Rochester, Minnesota.
UTI symptoms include a burning feeling when urinating, blood in the urine, a strong urge to urinate and urinating more often. Untreated, they can lead to complications including bladder infections and kidney damage.
“We absolutely need new antibiotics for uncomplicated UTIs,” Granberg said.
Blujepa is part of a new class of antibiotics called triazaacenaphthylenes, which work by targeting two key enzymes that E. coli bacteria need to copy itself and survive.
“In simple terms, this new antibiotic works its magic by using a novel binding method to block a bacteria’s ability to replicate,” Granberg said.
According to GSK, the last time the FDA cleared a new class of antibiotics for uncomplicated UTIs was in 1996, with the approval of fosfomycin. (Last year, the agency approved the drug Pivya for UTIs, which belongs to the penicillin drug class.)
In two phase 3 clinical trials of 3,000 adults and teens, Blujepa was shown to successfully treat 50% to 58% of patients’ infections when taken twice a day for five days, compared to 43% to 47% in a group that received the antibiotic nitrofurantoin.
More than half of women will experience at least one UTI in their lifetime, according to a 2019 report, and around 30% will experience a recurring infection.
GSK is also studying whether the drug can treat gonorrhea, according to Tony Wood, the company’s chief scientific officer.
Blujepa is expected to be available in the second half of the year. Wood didn’t disclose how much it would cost — although, as a brand-name drug, its cost is expected to be higher than other antibiotics that have been on the market for years and have generic options.
Shah, of Mount Sinai Hospital, said that cost is an important consideration, noting that physicians would likely gravitate toward generics. Still, the overuse of the same antibiotics can promote drug resistance, so a new option is helpful, he added.
