Regulator Authorizes New Oral Antibiotic Option for Gonorrhea
The drug, already approved for urinary tract infections, provides the first new drug class to combat the sexually transmitted infection in over three decades amid rising global resistance.
The U.S. Food and Drug Administration (FDA) has announced a decision to expand the usage approval for GSK’s antibiotic, Blujepa, specifically for the treatment of gonorrhea. This move introduces a novel class of therapeutic agent against the sexually transmitted infection (STI), marking a significant advancement for the first time in more than three decades.
This new authorization comes as clinicians face diminishing treatment options due to rising antimicrobial resistance to therapies for gonorrhea—an infection affecting over 80 million people globally each year.
Blujepa delivers an important oral alternative, unlike the currently administered injected therapies that serve as the standard of care for managing this infection. The medication was previously authorized by the FDA in March of this year for managing uncomplicated urinary tract infections.
The expanded clearance for gonorrhea is specifically for patients aged 12 and above, weighing a minimum of 45 kilograms (100 pounds). Its use is reserved for situations where the current standard-of-care (SOC) treatments are unsuitable, or where patients are intolerant or unwilling to use the first-line regimen.
Clinical data supporting the approval came from a Phase 3 study. The trial demonstrated that Blujepa’s efficacy was comparable to the established combination therapy of intramuscular ceftriaxone and oral azithromycin. Safety data indicated the medication was generally well-tolerated, with mild to moderate issues in the gastrointestinal tract being the most frequently observed adverse reactions.
An infectious disease specialist characterized the approval as a rare moment of progress in the fight against antibiotic resistance, especially for a pathogen that has overcome nearly every existing drug.
Gonorrhea is recognized by the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC) as a priority pathogen and an urgent public health threat. The drug’s development received partial funding from U.S. government agencies, including the Biomedical Advanced Research and Development Authority (BARDA).
Source: https://www.fiercepharma.com/pharma/gsk-gains-fda-expansion-antibiotic-blujepa-treatment-gonorrhea
