GSK launches new UTI antibiotic Blujepa after FDA approval

GSK is ushering in a transformative period for urinary tract infection (UTI) treatment with the introduction of Blujepa, the first new class of oral antibiotics for this common condition in almost three decades. Known scientifically as gepotidacin, Blujepa has received approval from the FDA to treat uncomplicated UTIs (uUTIs) in women aged 12 and older. These infections, often caused by bacteria like E. coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, or Enterococcus faecalis, affect more than half of all women at some point in their lives. Each year, around 16 million women in the U.S. suffer from these infections, highlighting the need for innovative treatments like Blujepa.

GSK conducted comprehensive testing for Blujepa through the phase 3 clinical trials known as Eagle-2 and Eagle-3. These trials compared Blujepa's effectiveness to that of nitrofurantoin, a long-established treatment for UTIs. In Eagle-2, Blujepa demonstrated a noninferior therapeutic success rate, achieving success in 50.6% of participants compared to nitrofurantoin's 47%. The Eagle-3 trial went a step further, showing Blujepa's statistically significant superiority, with 58.5% of participants achieving therapeutic success compared to only 43.6% for nitrofurantoin.

Tony Wood, Ph.D., GSK's Chief Scientific Officer, expressed pride in bringing Blujepa, a novel oral antibiotic for uUTIs, to the market. He emphasized the importance of providing new options for patients, particularly as recurrent infections and resistance to existing treatments continue to rise. GSK is planning to launch Blujepa in the latter half of the year, expanding the arsenal against UTIs and addressing the growing concern of antimicrobial resistance. Unlike nitrofurantoin and newer options such as Iterum’s Orlynvah (sulopenem) and Utility Therapeutics’ Pivya (pivmecillinam), Blujepa distinguishes itself through its unique mechanism of action. It specifically targets bacterial DNA in the E. coli class, which is responsible for most UTI infections. This targeted approach reduces the impact of antimicrobial resistance, which is a significant challenge for many other antibiotics.

In addition to its application for UTIs, GSK is testing Blujepa for the treatment of gonorrhea, another condition facing significant drug resistance issues. Moreover, GSK's pipeline includes a treatment for complicated UTIs in collaboration with Spero Therapeutics, featuring the antibiotic tebipenem HBr. This drug is currently undergoing phase 3 trials and aims to reduce hospitalizations from challenging infections.

Despite many large pharmaceutical companies stepping back from the less lucrative field of antibiotics, GSK continues to invest heavily, maintaining one of the largest and most varied infectious disease pipelines in the industry. The success of the Eagle trials for Blujepa highlights the challenges and triumphs in this field. Melanie Paff, Ph.D., head of GSK’s hepatitis B program, noted that these achievements were hard-earned, signifying the complex nature of innovation in antibiotics.

The approval of Blujepa marks GSK's second major regulatory success this year, as the company aims to secure five key approvals. Following Blujepa, GSK is focusing on expanding the applications of its antibody-drug conjugate Blenrep, its asthma medication Nucala, and launching the new biologic depemokimab. These developments are part of GSK's strategy to reach its ambitious sales target of over 40 billion pounds sterling ($50 billion) by 2031.