Meningococcal group B vaccine(GlaxoSmithKline Biologicals SA)

Gepotidacin is already available in the US under the brand name Blujepa for the treatment of urinary tract infections (UTI). Credit: 1take1shot via Shutterstock.com. 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. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence 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. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

As cases of the sexually transmitted disease reach historic highs, the NHS began rolling out the world's first routine gonorrhoea vaccination programme Monday, offering free immunisations at sexual health clinics across England to patients at highest risk of infection.Clinics will offer the 4CMenB vaccine – originally developed for meningococcal disease, but that also helps protect against gonorrhoea – to gay and bisexual men who have a recent history of multiple sexual partners and a bacterial sexually transmitted infection (STI) in the last 12 months."This roll out is hugely welcome as we're currently seeing very concerning numbers of gonorrhoea, including even more worryingly antibiotic-resistant gonorrhoea," said Sema Mandal, consultant epidemiologist at the UK Health Security Agency. According to the NHS, a record 85,000 cases of the disease were reported in England in 2023, three times higher than in 2012.The programme is expected to prevent up to 100,000 cases over the next decade and save the NHS an estimated £7.9 million ($10.5 million). It forms part of the UK government's Plan for Change, which aims to shift the health system's focus from treatment to prevention. Eligible patients will also continue to be offered other STI-related vaccinations, including those for hepatitis A and B, mpox and human papillomavirus (HPV).Pharmaceutical efforts to confront rising antimicrobial resistance in gonorrhoea include GSK's gepotidacin, an investigational oral treatment option with a novel dual-targeting mechanism. The company posted positive Phase III results from the EAGLE-1 trial last year, with gepotidacin achieving a 92.6% success rate against uncomplicated urogenital gonorrhoea caused by Neisseria gonorrhoeae, a rate comparable to the current standard of care.The drug was approved by the FDA earlier this year under the brand name Blujepa to treat uncomplicated urinary tract infections (see – Spotlight On: GSK swims against the tide to address growing AMR crisis). GSK has said it planned regulatory filings for gepotidacin as a possible gonorrhoea treatment this year.