Gepotidacin

GSK has secured an FDA label expansion for its antibiotic Blujepa to treat patients with gonorrhea. In March of this year, the U.S. regulator signed off on Blujepa as a treatment for uncomplicated urinary tract infections. With an increase in the antimicrobial resistance to therapies for gonorrhea, doctors have been left with fewer options to treat the sexually transmitted infection (STI), which strikes more an 80 million annually around the world.Thursday, the FDA addressed the shortfall with a label expansion for GSK’s Blujepa. The U.S. approval brings a new class of antibiotic treatment to gonorrhea for the first time in more than three decades. It also provides an oral option versus the injected therapies currently used to combat the infection.Blujepa already is on the market, as the U.S. regulator endorsed it in March of this year for an array of uncomplicated urinary tract infections.As for the gonorrhea nod, the FDA has cleared its use for those age 12 and older and who weigh at least 45 kg (100 pounds) in cases where standard of care (SOC) is contraindicated or in cases where patients are intolerant or unwilling to use the first line of treatment.Paving the way for the approval was a phase 3 trial which showed Blujepa was noninferior to the SOC combination therapy of intramuscular ceftriaxone plus oral azithromycin. The SOC antibiotics were originally approved by the FDA in 1982 and 1991, respectively. The study also demonstrated the safety and tolerability of the treatment, with mild to moderate gastrointestinal issues reported as the most common adverse reactions.Tyler Evans, M.D., an infectious disease specialist and the CEO of the Wellness Equity Alliance, called the approval a “rare moment of progress in the fight against antibiotic resistance.”“A first-in-class oral treatment for gonorrhea is a major scientific achievement, especially for a pathogen that has outsmarted nearly every drug we have used against it. Expanding treatment options matters, particularly for patients who face barriers to injectable therapy or have limited alternatives,” Evans added. If left untreated or inadequately treated, gonorrhea can lead to infertility and other sexual and reproductive health issues. In 2023, there were more than 600,000 cases of gonorrhea in the U.S., according to the Centers for Disease Control and Prevention (CDC), making it the second-most common STI after chlamydia. There is no vaccine in the U.S. for the prevention of gonorrhea, which is spread by unprotected sex and can affect the genitals, rectum, eyes and throat.Gonorrhea has been recognized by the World Health Organization and the U.S. CDC as a priority pathogen and an urgent public threat. The development of Blujepa was funded in part by the U.S. Department of Health and Human Services, the Administration for Strategic Preparedness and Response and the Biomedical Advanced Research and Development Authority, GSK said. Another oral antibiotic to treat gonorrhea is on the doorstep of approval in the U.S. as Massachusetts company Innoviva Specialty Therapeutics faces a Monday FDA decision date for zoliflodacin. Thursday, the company revealed (PDF) results from a phase 3 trial which showed the noninferiority of zoliflodacin to the ceftriaxone/azithromycin combo.