Latest news with #Rocephin
Yahoo
4 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.
Miami Herald
07-07-2025
- Health
- Miami Herald
Salmonella in South Florida grower's produce hospitalized woman, lawsuit claims
Salmonella symptoms — chills, vomiting, diarrhea — harsh enough to hospitalize a Mississippi woman for a week have been blamed on a Boynton Beach grower's cucumbers. And that grower has been linked to two major salmonella outbreaks over the past two springs. As of the last update from the U.S. Centers for Disease Control and Prevention, on June 30, the salmonella outbreak linked to Bedner Growers whole fresh cucumbers had hospitalized 22 people. One of those people is Brandi Jackson, of Pearl, Mississippi, according to her lawsuit filed in U.S. District Court for the Southern District of Mississippi. Booneville, Mississsippi's Casey Langston Lott of Langston & Lott is Jackson's lead attorney while Marler Clark's Bill Marler out of Washginton is vice counsel. No attorney has been listed for Bedner Growers on the court docket. The phone number for Bedner Growers has been disconnected. There was no response to an email sent through the Contact Us part of Bedner Farm Fresh Market's website. Bedner was sued in Palm Beach County court after the summer 2024 salmonella outbreak traced to cucumbers from Bedner and Boca Raton's Thomas Produce Company, an outbreak credited with 155 hospitalizations and at least 551 people infected. Salmonella official case counts tend to be much lower than actual case numbers because 98% of people heal without hospitalization. That case ended in voluntary dismissal, with each side paying its own attorney's fees. Cucumbers from Palm Beach County via Kroger Kroger issued a recall on whole cucumbers from Bedner on May 21, covering May 14 through May 21. But Jackson's lawsuit says she bought cucumbers at the Kroger in Pearl on May 13 and 'subsequently began experiencing symptoms including fever, severe chills, abdominal pain, nausea, vomiting, excessive sweating, and diarrhea.' That got worse through emergency room trips on May 18 and May 20, the latter leading to University of Mississippi Medical Center, where she was admitted. Doctors found colitis, as well as an infection in Jackson's abdominal wall. 'Her condition was debilitating,' the lawsuit said. 'She was unable to eat for several days and required extensive inpatient medical treatment until her discharge on May 27, 2025. Upon discharge, [Jackson] was sent home with a Mid-line IV catheter placed in her upper arm and was required to self-administer Rocephin (an intravenous antibiotic) for more than a week to continue treating the bloodstream infection.' The IV would be removed June 6.
