Latest news with #Gepotidacin
Yahoo
6 days ago
- Health
- Yahoo
GSK's oral antibiotic for gonorrhoea set for FDA review
A new pill that combats antibiotic-resistant strains of gonorrhoea has inched closer to approval in the US, after the US Food and Drug Administration (FDA) accepted GSK's gepotidacin for priority review. A priority review expedites the FDA's decision on a drug application, cutting review time down from 10 to six months. The agency has set a Prescription Drug User Fee Act (PDUFA) action date of 11 December 2025. If approved, it would be indicated for the treatment of uncomplicated urogenital gonorrhoea in patients aged 12 years and older who weigh at least 45kg. Gepotidacin is already available in the US under the brand name Blujepa for the treatment of urinary tract infections (UTI) in women and girls aged 12 years and above, courtesy of an FDA approval in March 2025. Currently, gonorrhoea treatment options in the US mostly rely on injectable drugs, such as Roche's Rocephin (ceftriaxone). While there are oral antibiotics approved by the FDA, these are often broad-use drugs such as Pfizer's Zithromax (azithromycin). In a Phase III trial (NCT04010539) that enrolled than 600 adults and teenagers, gepotidacin was shown to successfully treat about 92% of patients when taken twice daily. This was non-inferior when compared with a standard combination therapy of Rocephin and Zithromax, which had success rates of 91.2%. There were also no failures at the urogenital site due to bacterial persistence arising from gonorrhoea, signifying gepotidacin's important role against resistant strains. Data from the World Health Organization (WHO) shows a rise in the prevalence of multi-resistant gonorrhoea. As of 2023, out of 87 countries where enhanced gonorrhoea antimicrobial resistance surveillance was conducted, nine countries reported elevated levels of resistance to Rocephin. Antibiotic-resistant strains of gonorrhoea mean tackling its spread is harder at public health levels. Developed by GSK but with funding from US infectious disease grants, Gepotidacin is a triazaacenaphthylene antibiotic that inhibits bacterial DNA replication. The drug inhibits two different Type II topoisomerase enzymes, which gives it activity against a range of pathogens that target the urinary system. Another oral antibiotic could also be set to join gepotidacin in the US drug armoury against gonorrhoea. In June, the FDA accepted a new drug application for zoliflodacin, co-developed by Innoviva Specialty Therapeutics and Global Antibiotic Research & Development Partnership (GARDP). Zoliflodacin's PDUFA date is assigned for 15 December 2025, four days later than that for gepotidacin. A major milestone in the gonorrhoea treatment space occurred in the UK last week when the NHS rolled out free vaccines for those at high risk of infection. The GSK-developed 4CMenB vaccine is approved to prevent meningococcal B, but a UK vaccine committee recommended its off-label use to curb rising cases. It marks the first time in the world that a vaccine is being used to combat gonorrhoea. "GSK's oral antibiotic for gonorrhoea set for FDA review" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
India Today
21-04-2025
- Health
- India Today
UTI drug repurposed to treat sexually transmitted disease shows 93% efficacy
A new oral antibiotic could be a breakthrough in the fight against stubborn gonorrhoea infections, a sexually transmitted infection that health authorities warn is becoming harder to a clinical trial, the UTI drug gepotidacin cleared infections in 93% of cases, performing just as well as the current standard treatment, according to findings published in The caused by the bacterium Neisseria gonorrhoeae, is commonly spread through unprotected vaginal, oral, or anal sex. It often goes undetected in women due to the absence of However, if left untreated, it can lead to infertility, chronic pelvic pain, and increased HIV study tested gepotidacin (previously used for urinary tract infections) on 628 participants with uncomplicated gonorrhoea. Half received two doses of oral gepotidacin, while others were given an injection of ceftriaxone and an oral dose of azithromycin, the existing dual showed the pill was equally effective overall: 93% of participants who took gepotidacin were cured, compared to 91% in the standard group. Gonorrhoea, caused by the bacterium Neisseria gonorrhoeae, is commonly spread through unprotected vaginal, oral, or anal sex. () Gepotidacin was already being used to treat urinary tract infections, but this is the first time it has shown success against gonorrhoea. It works differently from current antibiotics by blocking the bacteria's DNA replication, making it effective even in cases with known found that the new drug was 100% effective against rectal gonorrhoea, though it showed lower efficacy for throat infections (78%) compared to 94% with the standard treatment. Further data is needed, particularly for pharyngeal infections and in broader people experienced mild issues like nausea or diarrhoea, but nothing serious was trial results come as the UK faces a rise in antibiotic-resistant gonorrhoea. According to the UK Health Security Agency (UKHSA), 17 cases of ceftriaxone-resistant gonorrhoea were reported from January 2024 to March 2025, including nine that were extensively Katy Sinka from UKHSA warned that the infection is becoming increasingly difficult to treat and urged people with new or casual partners to get tested. Experts also cautioned that gepotidacin's use should be monitored carefully to prevent future while gepotidacin does bring hope, experts are warning caution especially for people who can't take injections or who have infections that don't respond to current drugs. If this new treatment is overused, resistance could build up why continued STI prevention, regular testing, and developing even more treatment options remain crucial in antimicrobial resistance.
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
14-04-2025
- Health
- Yahoo
A new type of antibiotic pill may treat drug-resistant gonorrhea. It could be available this year.
A pill developed by GSK was found to be safe and effective in treating gonorrhea in a late-stage clinical trial, according to a study published Monday in The Lancet. If approved, it would become the first new class of antibiotic for the sexually transmitted infection in more than two decades. The pill, called gepotidacin, was approved by the Food and Drug Administration in March to treat uncomplicated urinary tract infections in women and girls 12 and up — the most common type of infection in women. The drug is sold under the name Blujepa. A new treatment option is important, experts say, because bacteria that commonly cause STIs are increasingly becoming resistant to the standard antibiotics, making treatment more difficult. There are an estimated 82 million new cases of gonorrhea globally each year, according to GSK. In the United States, rates of reported gonorrhea have increased 118% from 2009 to 2021, with more than 640,000 cases being reported to the Centers for Disease Control and Prevention in 2022. Gonorrhea has developed resistance to nearly all the antibiotics used for its treatment, according to the CDC. If left untreated, gonorrhea can lead to serious health complications, including swollen and painful joints, liver inflammation, and heart and brain damage. It can also increase the risk of infertility in women. Gepotidacin is part of a new class of antibiotics called triazaacenaphthylenes, which work by targeting two key enzymes that gonorrhea needs to copy itself and survive. In a Phase 3 clinical trial of more than 600 adults and teens, gepotidacin was shown to successfully treat about 92% of patients when taken twice daily, compared with about 91% in a group of patients who got a standard treatment. The most common side effect was gastrointestinal issues, with almost all reported being 'mild or moderate.' Crucially, the study authors wrote, the pill was effective against strains of gonorrhea bacteria that are resistant to existing antibiotics. Dr. Sovrin Shah, an associate professor of urology at Mount Sinai Hospital in New York who was not involved in the study, called the GSK pill 'a welcome addition.' 'Antibiotic-resistant gonorrhea is a public health concern,' Shah said. 'The rate of STIs is significant in the U.S.' David Harvey, executive director of the National Coalition of STD Directors, said 'we desperately need effective cures to combat gonorrhea,' but noted that widespread job cuts at the federal health agencies, including to a lab that tracked STIs, could make it challenging. 'The recent closure of the CDC's key STI lab — which helps us understand which antibiotics are still effective and when we need to engage new drugs like this — poses a significant new obstacle,' Harvey said. A spokesperson for GSK said the company plans to file approval with the FDA 'in the coming months' with a regulatory decision expected in the second half of the year. The company said it's seeking approval for gepotidacin as an alternative to first-line therapy when such treatment is inappropriate — such as when the patient is intolerant to the existing treatment or unwilling to use it. In an editorial that accompanied the study, Magnus Unemo, director of the World Health Organization's division that oversees gonorrhea, said GSK's pill is 'promising,' but added that challenges to keep gonorrhea as a treatable infection will continue. Unemo also stressed improved prevention, including the promotion of safe sex and condom use, early diagnosis and surveillance. This article was originally published on
NBC News
14-04-2025
- Health
- NBC News
New pill is effective against gonorrhea as antibiotic resistance surges, study shows
A pill developed by GSK was found to be safe and effective in treating gonorrhea in a late-stage clinical trial, according to a study published Monday in The Lancet. If approved, it would become the first new class of antibiotic for the sexually transmitted infection in more than two decades. The pill, called gepotidacin, was approved by the Food and Drug Administration in March to treat uncomplicated urinary tract infections in women and girls 12 and up — the most common type of infection in women. The drug is sold under the name Blujepa. A new treatment option is important, experts say, because bacteria that commonly cause STDs are increasingly becoming resistant to the standard antibiotics, making treatment more difficult. There are an estimated 82 million new cases of gonorrhea globally each year, according to GSK. In the United States, rates of reported gonorrhea have increased 118% from 2009 to 2021, with more than 640,000 cases being reported to the Centers for Disease Control and Prevention in 2022. Gonorrhea has developed resistance to nearly all the antibiotics used for its treatment, according to the CDC. If left untreated, gonorrhea can lead to serious health complications, including swollen and painful joints, liver inflammation and heart and brain damage. It can also increase the risk of infertility in women. Gepotidacin is part of a new class of antibiotics called triazaacenaphthylenes, which work by targeting two key enzymes that gonorrhea needs to copy itself and survive. In a phase 3 clinical trial of more than 600 adults and teens, gepotidacin was shown to successfully treat about 92% of patients when taken twice daily, compared to about 91% in a group of patients who got a standard treatment. The most common side effect was gastrointestinal issues, with almost all reported being 'mild or moderate.' Crucially, the study authors wrote, the pill was effective against strains of gonorrhea bacteria that are resistant to existing antibiotics. Dr. Sovrin Shah, an associate professor of urology at Mount Sinai Hospital in New York who was not involved in the study, called the GSK pill 'a welcome addition.' 'Antibiotic-resistant gonorrhea is a public health concern,' Shah said. 'The rate of STIs is significant in the U.S.' A spokesperson for GSK said the company plans to file approval with the FDA 'in the coming months' with a regulatory decision expected in the second half of the year. The company said it's seeking approval for gepotidacin as an alternative to first-line therapy when such treatment is inappropriate — such as when the patient is intolerant to the existing treatment or unwilling to use it. The company is also investigating whether gepotidacin works in other sexually transmitted diseases. In an editorial that accompanied the study, Magnus Unemo, director of the World Health Organization's division that oversees gonorrhea, said GSK's pill is 'promising,' but added that challenges to keep gonorrhea as a treatable infection will continue. Unemo also stressed improved prevention, including the promotion of safe sex and condom use, early diagnosis and surveillance.
