Latest news with #Blujepa
Time Magazine
08-05-2025
- Health
- Time Magazine
Emma Walmsley
Antibiotics are the workhorses of the medical world, critical for controlling infections and saving lives but rarely grabbing the attention that blockbuster treatments often do. Dame Emma Walmsley, CEO of the pharmaceutical company GSK, admits they have become 'unfashionable.' But a new antibiotic for treating urinary tract infections (UTIs) might change that. In March, her team at GSK received approval from the U.S. Food and Drug Administration (FDA) for a new type of antibiotic, Blujepa, that interrupts the ability of UTI-causing bacteria, E. coli, to replicate. The drug targets two enzymes that E. coli use to untangle their genetic material in order to proliferate. And because Blujepa works through a novel approach, scientists hope the drug will make it harder for the bacteria to develop resistance against it. Focusing on a new antibiotic for UTIs, which haven't had a novel therapy in decades, was intentional, Walmsley says. Half of women have a UTI at least once in their lifetime, and many experience repeat infections, raising the risk that the bacteria may become resistant to the antibiotics they take. Walmsley says GSK is also developing a different antibiotic to treat more complicated UTI cases as well. Walmsley anticipates three more drugs potentially receiving FDA approval in the coming year, and says there are about a dozen promising medications in the pipeline.
Reuters
16-04-2025
- Health
- Reuters
Health Rounds: Appendectomy appears to reduce ulcerative colitis relapses
April 16 (Reuters) - (To receive the full newsletter in your inbox for free sign up here) Patients with the chronic inflammatory bowel disease ulcerative colitis might reduce their risk of a relapse by having their appendix removed, a new study suggests. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. Ulcerative colitis causes inflammation and ulcers in the large intestine and rectum, with diarrhea and abdominal pain. There is no cure. Symptoms repeatedly subside and relapse and can adversely affect quality of life. The appendix is thought to play a role in all of this by producing inflammatory proteins that trigger the body to produce cascades of immune responses, according to a report of the study published in The Lancet Gastroenterology & Hepatology, opens new tab. All 197 adult patients in the current study were in remission at the start but had required treatment for an episode of active disease during the previous year. All of them received the usual standard care. Half also had an appendectomy. A year later, the relapse rates were 36% in the appendectomy group and 56% in the usual-care group, the researchers said. In addition, fewer patients in the appendectomy group later developed more severe disease requiring treatment with biological agents. There were five postoperative complications in the surgery group, including two that were labeled serious. After accounting for patients' individual risk factors, the odds of relapse during the study were 35% lower with appendectomy. 'This significant... reduction suggests that appendectomy might be a viable additional therapeutic option for maintaining remission in ulcerative colitis,' the researchers wrote. 'Furthermore, patients who underwent appendectomy were significantly more likely to maintain lower disease activity, reduce the initiation of biological agents, and improve health-related quality of life compared with patients who received standard medical therapy alone.' An editorial, opens new tab published with the study notes that a separate trial, still underway, is testing the benefit of appendectomy in patients whose ulcerative colitis is not in remission. GSK ANTIBIOTIC SHOWS PROMISE FOR GONORRHEA GSK's (GSK.L), opens new tab new pill for uncomplicated urinary tract infections in women and girls is also showing promise for treating uncomplicated gonorrhea, the company reported on Monday in The Lancet, opens new tab. Gepotidacin, sold as Blujepa, is a first-in-class triazaacenaphthylene antibiotic that acts by inhibiting bacteria's replication of DNA. In a late-stage, multi-nation trial, researchers randomly assigned 628 patients with gonorrhea in the urinary tract or genitals to treatment with gepotidacin or ceftriaxone with azithromycin. Success rates at eradicating Neisseria gonorrhoeae bacteria were statistically similar, at 92.6% with gepotidacin and 91.2% with ceftriaxone plus azithromycin. The gepotidacin group had higher rates of drug-related gastrointestinal adverse side effects, but almost all were mild or moderate, according to the researchers. An editorial, opens new tab published with the report notes that no new antimicrobials have been introduced for gonorrhoea treatment since the 1990s. The authors of the editorial expect N. gonorrhoeae to eventually develop resistance to gepotidacin, too. However, they said gepotidacin should also be tested in patients with gonorrhea of the mouth and throat, which is harder to treat than the urogenital infections seen in the current trial. An editorial in The Lancet Infectious Diseases, opens new tab notes that in a separate late-stage study, the first-in-class spiropyrimidinetrione antibiotic zoliflodacin was just as effective against urogenital gonorrhea as ceftriaxone plus azithromycin. Zoliflodacin is being developed as part of a public-private partnership between Innoviva's (INVA.O), opens new tab specialty therapeutics unit and the Global Antibiotic Research & Development Partnership.
Yahoo
15-04-2025
- Health
- Yahoo
New antibiotic could treat drug-resistant gonorrhea: Study
A new class of antibiotic has been found to be safe and effective in treating gonorrhea in late-stage trials, according to a new study published Monday in The Lancet. The drug, called gepotidacin, works by preventing bacteria from replicating in the body and was approved by the Food and Drug Administration in March to treat uncomplicated urinary tract infections in women and in girls 12 years and older. If approved to treat gonorrhea, it will be the newest antibiotic to treat the sexually transmitted infection since the 1990s. The drug is manufactured by the pharmaceutical company GSK and is sold under the name Blujepa. After reaching a historic low in 2009, cases of gonorrhea in the United States steadily increased until 2021 and have slowly declined since then, according to the Centers for Disease Control and Prevention (CDC). Still, gonorrhea is the second most common sexually transmitted infection in the country with, 601,319 reported cases in 2023, according to the agency. Gonorrhea, and other sexually transmitted infections, are becoming more difficult to treat as they become increasingly more resistant to existing antibiotics. The CDC currently recommends providers treat gonorrhea with a 500 mg injection of the antibiotic ceftriaxone. The agency updated its treatment guidelines in 2023, directing providers to administer a higher dose of the drug to combat antibiotic resistance. Justin Gill, an urgent care nurse practitioner and president of the Washington State Nurses Association, told The Hill that he frequently treats gonorrhea and has encountered cases of the infection that are resistant to ceftriaxone. 'There are only a handful of antibiotics that are available as backup options,' he said. 'The development of new antibiotics has been slow, but federal investment in new and emerging antibiotic options is necessary before resistant strains of gonorrhea expand further.' If left untreated, gonorrhea can cause serious health complications that can lead to infertility in both men and women, and it can increase the odds of contracting and passing HIV, according to the CDC. The trial of more than 620 people showed gepotidacin was about 92 percent effective in treating the infection among those who took the drug twice a day. Meanwhile, a regimen of combination ceftriaxone and azithromycin was about 91 percent effective. Stuart Ray, an infectious disease professor at Johns Hopkins University School of Medicine who did not take part in the study, said that any progress in safely and effectively treating gonorrhea is 'exciting.' He added that the fact that the drug can be administered in pill form makes it 'attractive.' 'In general, it's very exciting to see a late-stage trial for a new antimicrobial for a thorny problem like gonorrhea,' he said. 'I think it's very exciting to see data and progression of an agent this far down the path.' Ray said that of the more than 600 trial participants, less than 10 percent were women. 'We have to be careful about making conclusions about subgroups that may have been somewhat underrepresented.' Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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.
The Hill
14-04-2025
- Health
- The Hill
New antibiotic could treat drug-resistant gonorrhea, study says
A new class of antibiotic has been found to be safe and effective in treating gonorrhea in late-stage trials, according to a new study published Monday in The Lancet. The drug, called gepotidacin, works by preventing bacteria from replicating in the body and was approved by the Food and Drug Administration in March to treat uncomplicated urinary tract infections in women and in girls 12 years and older. If approved to treat gonorrhea, it will be the newest antibiotic to treat the sexually transmitted infection since the 1990s. The drug is manufactured by the pharmaceutical company GSK and is sold under the name Blujepa. After reaching a historic low in 2009, cases of gonorrhea in the United States steadily increased until 2021 and have slowly declined since then, according to the Centers for Disease Control and Prevention (CDC). Still, gonorrhea is the second most common sexually transmitted infection in the country with 601,319 reported cases in 2023, according to the agency. Gonorrhea, and other STIs, are becoming more difficult to treat as they become increasingly more resistant to existing antibiotics. The CDC currently recommends providers treat gonorrhea with a 500 mg injection of the antibiotic ceftriaxone. The agency updated its treatment guidelines in 2023, directing providers to administer a higher dose of the drug to combat antibiotic resistance. Justin Gill, an urgent care nurse practitioner and president of the Washington State Nurses Association, told The Hill that he frequently treats gonorrhea and has encountered cases of the infection that are resistant to ceftriaxone. 'There are only a handful of antibiotics that are available as backup options,' he said. 'The development of new antibiotics has been slow, but federal investment in new and emerging antibiotic options is necessary before resistant strains of gonorrhea expand further.' If left untreated, gonorrhea can cause serious health complications which can lead to infertility in both men and women, as well as increasing the odds of contracting and passing HIV, according to the CDC. The trial of more than 620 people showed gepotidacin was about 92 percent effective in treating the infection among those who took the drug twice a day. Meanwhile, a regimen of combination ceftriaxone and azithromycin was about 91 percent effective. Stuart Ray, an infectious disease professor at Johns Hopkins University School of Medicine who did not take part in the study, said that any progress in safely and effectively treating gonorrhea is 'exciting.' He added that the fact that the drug can be administered in pill form makes it 'attractive.' 'In general, it's very exciting to see a late-stage trial for a new antimicrobial for a thorny problem like gonorrhea,' he said. 'I think it's very exciting to see data and progression of an agent this far down the path.' Ray said that of the more than 600 trial participants, less than 10 percent were women. 'We have to be careful about making conclusions about subgroups that may have been somewhat underrepresented.'
