Latest news with #Pivya
CNN
14-04-2025
- Health
- CNN
Millions of women get painful UTIs that keep coming back. A new kind of antibiotic may help break the cycle
The US Food and Drug Administration has approved a new type of antibiotic to treat urinary tract infections. The pill, gepotidacin, will be sold under the brand name Blujepa and is expected to be available in the second half of 2025. Blujepa is approved to treat females 12 and older with uncomplicated urinary tract infections, or UTIs. About half of all women will experience a UTI at some point in their lives, and about 30% will have a UTI that comes back after treatment, drugmaker GSK said. Recurrent UTIs have become a bigger problem as the bacteria that cause them have become more resistant to the antibiotics available to treat them. Blujepa is the first new type of oral antibiotic to treat UTIs to gain approval in more than 20 years. Its development was funded in part by grants from the US government's Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency. Dr. Tony Wood, chief scientific officer of GSK, said in a statement that Blujepa's approval is 'a crucial milestone.' 'We are proud to have developed Blujepa, the first in a new class of oral antibiotics for [uncomplicated UTIs] in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments,' the statement said. Other antibiotics have recently been approved for UTIs, although they fit into existing drug classes. Pivya, a type of penicillin, was approved in April 2024 to treat uncomplicated UTIs, and Orlynvah was approved in December 2024 to treat uncomplicated UTIs in women who have limited or no other antibiotic treatment options. Blujepa is what's known as a triazaacenaphthylene antibiotic and it's the first of its kind. UTIs are the cause of roughly 8 million emergency room visits and 100,000 hospitalizations in the US each year, GSK said. They strike women more often than men. Blujepa works by interfering with two enzymes that bacteria need to copy themselves. Because its mechanism of action is targeted, it may cut down on the possibility that bacteria will become resistant to it, Wood said Monday during a call with reporters. In clinical trials with more than 3,000 women and teen girls, the drug - a pill taken twice daily - performed as well as or better than nitrofurantoin, the frontline antibiotic which is currently used to treat UTIs. Its main side effects were diarrhea, which affected 16% of patients in the clinical trial, and nausea, which affected 9% of participants. Most of these events were considered mild. Symptoms of UTIs include frequent urination that is painful or burns, bloody urine, low stomach cramps and the need to urinate even after having just gone.
Yahoo
14-04-2025
- Health
- Yahoo
A growing number of UTIs are resistant to antibiotics. Experts say it's the 'canary in the coal mine' for a bigger problem.
Mo Carrier has dealt with recurrent urinary tract infections, defined as having three or more UTIs per year or two infections within six months, since her early 20s. 'I ended up being put on antibiotics to be used before every sexual act,' she tells Yahoo Life. Carrier eventually switched doctors and says her access to antibiotics changed. Among other things, her new doctor was concerned about antibiotic resistance, which happens when the bacteria no longer responds to certain antibiotics. 'I'd used [antibiotics] probably three times a week for about a year at that point,' she says. Carrier says she was 'terrified' that the antibiotics would one day stop working for her. 'UTIs were one of the worst things I've been through,' she adds. Liz S. also struggles with recurrent UTIs, but has another challenge: She's allergic to sulfa-based antibiotics, which limits the type of medication she can take. Liz tells Yahoo Life that antibiotic resistance is 'definitely a concern, given that I can't take one of the three standard medications.' In March 2025, the Food and Drug Administration approved a new medication — gepotidacin, sold under the brand name Blujepa — to treat UTIs, making it the first new antibiotic class in nearly 30 years. That's good news for the more than 50% of women who will have at least one UTI in their lifetime, along with the 30-44% of women whose UTI will inevitably return in a matter of months. (Drugs Pivya and Orlynvah were approved in 2024 to treat UTIs, but they fit into existing antibiotic classes; Blujepa is a triazaacenaphthylene antibiotic and is the first of its kind.) Why all the new medications? Recurrent UTIs have become a growing problem due to antibiotic resistance, meaning some of the drugs that were once used to treat them are no longer effective. Research suggests that 92% of bacteria that cause UTIs are resistant to at least one antibiotic, and nearly 80% are resistant to at least two antibiotics — and that's raising some red flags. But the problem with antibiotic resistance is bigger than just UTIs. The World Health Organization (WHO) has labeled antibiotic resistance as one of the three greatest threats to global health. The National Institutes of Health (NIH) says it's a serious threat, while research calls antibiotic resistance a 'global health emergency.' 'Antibiotic-resistant UTIs are the canary in the coal mine for broader antibiotic resistance,' Dr. Robert Bonomo, antibiotic resistance researcher and professor in the Department of Medicine at the Case Western Reserve University School of Medicine, tells Yahoo Life. Bonomo says that doctors will often prescribe many antibiotics over time to treat these recurrent infections, raising the risk that bacteria will adapt and eventually thwart the medication's effects. 'Since UTIs often require multiple rounds of antibiotics, they can drive resistance further, making it more likely that other infections — like pneumonia or bloodstream infections — will also become harder to treat,' Daniel Park, senior research scientist at the George Washington University Milken Institute School of Public Health, tells Yahoo Life. Antibiotic resistance can lead to potentially untreatable infections, Dr. Milner Staub, assistant professor of medicine in the Division of Infectious Diseases at Vanderbilt University Medical Center, tells Yahoo Life, which can be fatal. Predictive models estimate that more than 39 million people globally could die from antibiotic-resistant infections over the next 25 years, according to a 2024 study published in The Lancet. 'Antibiotic resistance is a major threat to human health,' Dr. Kelly Dooley, director of the Division of Infectious Disease at Vanderbilt University Medical Center, tells Yahoo Life. 'We know that antimicrobially resistant (AMR) pathogens will kill more people than cancer by 2050.' AMR impacts all areas of medicine, including oncology, surgery and transplants, Dooley says. Adding to the urgency: Doctors are running out of effective antibiotics to treat serious infections, Dr. Martin J. Blaser, director of the Center for Advanced Biotechnology and Medicine at Rutgers University, tells Yahoo Life. The problem has extended to other infections beyond UTIs, including antibiotic-resistant gonorrhea. 'We have taken for granted that effective antibiotics will be there when needed, as they have been for the past 80 years,' Blaser says. 'But resistance is increasing faster than we can develop new antibiotics.' Although antibiotic resistance is concerning, there are steps people can take to reduce the risk: Talk to your doctor about whether an antibiotic is needed. 'With mild infections, as most infections are, waiting a while will often show that the infection goes away on its own, so the antibiotic is not even needed,' says Blaser. However, it's important to talk to your doctor about this since some infections won't clear up without the right course of antibiotics. Take antibiotics only when prescribed. It's important to wait for culture results to make sure that you're given the right antibiotic for your particular infection, Blaser says. Finish the entire course of antibiotics. Park says it's important to complete the full course of antibiotics you're prescribed, even if you start to feel better before then. 'This prevents surviving bacteria from developing resistance,' he says. Try to purchase meat, poultry and dairy products raised without antibiotics when possible. 'This helps reduce overuse of antibiotics in agriculture, which reduces antimicrobial resistance, especially in zoonotic infections where the bacteria spreads from animals to humans,' Park says. While Bonomo says several new antibiotics are being researched, he also stresses the importance of doctors and patients working together to fight antibiotic resistance. 'We can cut down on the use of antibiotics by a lot and by not prescribing them for things like the common cold,' he says. 'I understand that sometimes pressures in the [doctor's] office are very high — people don't ... a prescription to take Tylenol and orange juice — but we need to do better.'
Yahoo
25-03-2025
- Health
- Yahoo
FDA approves first new antibiotic for UTIs in nearly 30 years
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. This article was originally published on
NBC News
25-03-2025
- Health
- NBC News
FDA approves first new antibiotic for UTIs in nearly 30 years
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.
CNN
25-03-2025
- Health
- CNN
Millions of women get painful UTIs that keep coming back. A new kind of antibiotic may help break the cycle
The US Food and Drug Administration has approved a new type of antibiotic to treat urinary tract infections. The pill, gepotidacin, will be sold under the brand name Blujepa and is expected to be available in the second half of 2025. Blujepa is approved to treat females 12 and older with uncomplicated urinary tract infections, or UTIs. About half of all women will experience a UTI at some point in their lives, and about 30% will have a UTI that comes back after treatment, drugmaker GSK said. Recurrent UTIs have become a bigger problem as the bacteria that cause them have become more resistant to the antibiotics available to treat them. Blujepa is the first new type of oral antibiotic to treat UTIs to gain approval in more than 20 years. Its development was funded in part by grants from the US government's Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency. Dr. Tony Wood, chief scientific officer of GSK, said in a statement that Blujepa's approval is 'a crucial milestone.' 'We are proud to have developed Blujepa, the first in a new class of oral antibiotics for [uncomplicated UTIs] in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments,' the statement said. Other antibiotics have recently been approved for UTIs, although they fit into existing drug classes. Pivya, a type of penicillin, was approved in April 2024 to treat uncomplicated UTIs, and Orlynvah was approved in December 2024 to treat uncomplicated UTIs in women who have limited or no other antibiotic treatment options. Blujepa is what's known as a triazaacenaphthylene antibiotic and it's the first of its kind. UTIs are the cause of roughly 8 million emergency room visits and 100,000 hospitalizations in the US each year, GSK said. They strike women more often than men. Blujepa works by interfering with two enzymes that bacteria need to copy themselves. Because its mechanism of action is targeted, it may cut down on the possibility that bacteria will become resistant to it, Wood said Monday during a call with reporters. In clinical trials with more than 3,000 women and teen girls, the drug - a pill taken twice daily - performed as well as or better than nitrofurantoin, the frontline antibiotic which is currently used to treat UTIs. Its main side effects were diarrhea, which affected 16% of patients in the clinical trial, and nausea, which affected 9% of participants. Most of these events were considered mild. Symptoms of UTIs include frequent urination that is painful or burns, bloody urine, low stomach cramps and the need to urinate even after having just gone.
