Food and Drug Administration on Tuesday Approved The first drug of a new class of antibiotics to treat urinary tract infections – it first happened in nearly 30 years.
The drug, called Blujepa from drug maker GSK, has been approved for women and girls, women and girls. It is caused by bacteria including E. coli.
Most UTIs are easy to treat and are usually cleaned up within days or weeks after a short course of antibiotics.
But the bacteria that commonly cause them are becoming increasingly resistant to standard antibiotics, making treatment even more difficult, said Dr. Sovereign Sher, an associate professor of urology at Mount Sinai Hospital in New York.
Over 2.8 million antibiotic-resistant infections occur annually in the United States. Centers for Disease Control and Prevention. a A survey found for 2019 Resistance to at least one drug of 92% or more of the bacteria that can cause UTIs. Approximately 80% showed resistance to at least two.
Developing new antibiotics that attack bacteria in a variety of ways reduces the risk of drug resistance and helps keep treatment options open.
Symptoms of UTI include burning heat when urinating, blood in the urine, and the strong urge to urinate more frequently and urinate. Without treatment, it can lead to complications such as bladder infections and kidney damage.
“A UTI with no complications definitely requires new antibiotics,” Grunberg said.
Blujepa is part of a new class of antibiotics called triazacenaphthylene, which works by targeting two important enzymes E. coli bacteria are required to copy and survive.
“Simply put, this new antibiotic makes the magic work by blocking the ability of bacteria to replicate using a new binding method,” Grunberg said.
According to GSK, the last time the FDA cleared a new class of antibiotics with no complications was in 1996 with the approval of Fosfomycin. (Last year, the agency approved the drug Pivya from UTIS, which belongs to the drug class of penicillin.)
In two phase 3 clinical trials of 3,000 adults and teens, Blujepa was shown to normally treat 50% to 58% of patients’ infections when taken twice daily for five days, when taken twice daily for five days, 50% to 58% of patients’ infections.
According to a 2019 report, more than half of women experience at least one UTI in their lifetime, with about 30% experiencing a recurrence of infection.
GSK is also studying whether drugs can treat go disease, according to Tony Wood, the company’s chief science officer.
Blujepa is expected to be available later this year. Wood did not reveal how much it would cost, but as a branded drug, its costs are expected to be higher than other antibiotics that have been on the market for years and have a common choice.
Shah of Sinai Mountain Hospital said costs are an important consideration and that doctors are likely to be drawn to generics. Still, he added that new options will help, as overuse of the same antibiotics may promote drug resistance.
