NBC News
The Food and Medicines Administration (FDA) on Tuesday approved the first drug of a new class of antibiotics to greatly urinary infections (UTI, in English), something that had not happened for almost 30 years.
The drug, a tablet called Blujepa of the Pharmaceutical GSK, was approved for women and girls over 12 years with uncomplicated urinary infections, the most common type of infection in women, often caused by bacteria such as E. coli.
Most urinary infections are easy to treat and usually disappear in a few days or weeks after a brief antibiotic treatment.
But the bacteria that usually cause them are increasingly resistant to the usual antibiotics, which makes treatment difficult, according to Dr. Sovrin Shah, associate professor of Urology at Mount Sinai Hospital in New York.
More than 2.8 million infections resistant to antimicrobials occur in the United States every year, according to the centers for disease control and prevention (CDC). A 2019 study found resistance to at least one medication in more than 92% of bacteria that can cause UTI. About 80% showed resistance to at least two.
The development of new antibiotics that attack bacteria in different ways reduces the risk of medication resistance, which helps vary the treatment options, explained Dr. Candace Granberg, Pediatric Urologist and Surgeon Mayo Chief of Mayic Children’s in Rochester, Minnesota.
The Symptoms of the UTI include burning sensation when urinating, blood in the urine, strong desire to urinate and urine more frequent. If they are not treated, they can cause complications such as bladder infections and kidney damage.
“We need new antibiotics for uncomplicated urinary infections,” said Granberg.
Blujepa is part of a new class of antibiotics called triazaActophytic, which act on two key enzymes that the E. coli needs to copy itself and survive.
“In a nutshell, this new antibiotic acts using a new method of union to block the ability to replicate bacteria,” said Granberg.
The last time the FDA authorized a new type of antibiotic for uncomplicated urinary infections was in 1996, with the approval of phosphomicin, GSK added. Last year, the agency approved the Pivya medication for the UTI, which belongs to the penicillin drug class.
In two phase 3 clinical trials with 3,000 adults and adolescents, it was shown that Blujepa was successfully treated between 50% and 58% of patient infections when taken twice a day for five days, compared to 43% and 47% of a group that received the nitrofurantoin antibiotic.
More than half of women will suffer at least one urinary infection throughout their lives, and about 30% will suffer from a recurring infection, according to a 2019 report.
GSK is also studying whether the drug can treat gonorrhea, according to Tony Wood, scientific director of the company.
Blujepa is expected to be available in the second half of the year. Wood did not reveal how much it will cost, although, since it is a brand medication, its cost is expected to be higher than other antibiotics that have been in the market for years and have generic options.
Shah, from the Mount Sinai Hospital, added that the cost is an important consideration, noting that doctors would probably be inclined to the genericians. However, the excessive use of the antibiotics can encourage drug resistance, so a new option is useful, he said.
