GSK Blujepa gets USFDA approval as oral option for uncomplicated urogenital gonorrhoea

London: GSK has announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application for gepotidacin as an oral option for adult and paediatric patients from 12 years of age weighing at least 45 kg who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhoea caused by susceptible strains of Neisseria gonorrhoeae (e.g., where standard of care is contraindicated, or where patients are intolerant or unwilling to use first line treatment).

This approval follows the US FDA approval of gepotidacin earlier this year as an oral treatment for female adult and paediatric patients 12 years of age and older (weighing ≥40 kg) with uncomplicated urinary tract infection (uUTI).

Gonorrhoea is a common, sexually transmitted infection caused by Neisseria gonorrhoeae, which has been recognised by the World Health Organization as a priority pathogen and an urgent public health threat by the US Centers for Disease Control and Prevention (CDC). It affects both men and women and if left untreated or inadequately treated, it can lead to infertility and other sexual and reproductive health complications. In 2023, there were over 600,000 cases of gonorrhoea reported in the United States according to the CDC, making it the second most commonly reported sexually transmitted infection in the country. There is currently no licensed vaccine in the US for the prevention of gonorrhoea infections and the standard treatment relies on an injectable antibiotic.

Tony Wood, Chief Scientific Officer, GSK, said, “We’re proud to have delivered the first new class of antibiotics for gonorrhoea in over three decades and a new oral option for US patients. The ability of N. gonorrhoeae to develop resistance to currently available options, including standard of care, makes it important to expand the range of effective oral treatments”.

The US application was based on positive results from the EAGLE-1 phase III trial which demonstrated that gepotidacin was non-inferior to standard of care combination treatment for gonorrhoea (intramuscular ceftriaxone plus oral azithromycin). The trial also supported the safety and tolerability profile of gepotidacin, with no serious drug related adverse events observed in either the gepotidacin or the comparator arm.

With this approval, gepotidacin is now available to US patients for the treatment of uncomplicated urogenital gonorrhoea when appropriate.

The development of gepotidacin has been funded in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Agreement number HHSO100201300011C based on its potential for use against secondary bacterial infections that may arise following chemical, biological, radiological, and nuclear (CBRN) incidents and with federal funds awarded by the US Department of Defense’s Threat Reduction Agency under agreement number HDTRA1-07-9-0002.