GSK’s Blujepa secures FDA approval for first new oral UTI antibiotic class in nearly 30 years

UK— British pharmaceutical giant GSK has secured FDA approval for its innovative antibiotic, Blujepa, also known as gepotidacin, for the treatment of urinary tract infections (UTIs).

This marks the first new class of oral antibiotics for uncomplicated UTIs in nearly three decades, offering a much-needed alternative for millions of women worldwide.

Blujepa is specifically designed to combat uncomplicated urinary tract infections (UTIs) caused by common bacteria, including Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.

These infections are prevalent among women, with over half experiencing at least one UTI in their lifetime.

Moreover, approximately 30% of women face recurrent infections, which can significantly impact their quality of life.

In the U.S. alone, up to 16 million women are affected annually, making Blujepa a timely and crucial addition to the treatment arsenal.

GSK conducted extensive phase 3 trials, known as Eagle-2 and Eagle-3, to test Blujepa’s efficacy.

In these trials, Blujepa was compared to nitrofurantoin, a long-standing standard treatment for uncomplicated UTIs.

The results were promising: in Eagle-2, Blujepa demonstrated non-inferiority to nitrofurantoin, with therapeutic success achieved in 50.6% of participants compared to 47% for nitrofurantoin.

More impressively, Eagle-3 demonstrated Blujepa to be statistically superior, with 58.5% of patients achieving therapeutic success compared to 43.6% on nitrofurantoin.

Chief Scientific Officer Tony Wood, Ph.D., expressed pride in GSK’s achievement, highlighting the need for new treatments due to the recurrence of infections and the rising resistance to existing therapies.

Blujepa’s unique mechanism of action sets it apart from other antibiotics, including newer options like Iterum’s Orlynvah and Utility Therapeutics’ Pivya.

Specifically, Blujepa targets bacterial DNA in E. coli, which is responsible for the majority of UTI infections.

This targeted approach reduces the likelihood of antimicrobial resistance, a growing concern that diminishes the effectiveness of many current treatments.

GSK’s commitment to developing antibiotics is noteworthy, as many pharmaceutical companies have shifted focus away from this area due to its challenges and lower profitability.

However, GSK continues to invest heavily in infectious diseases, boasting one of the largest and most diverse pipelines in the industry.

The approval of Blujepa is part of GSK’s broader strategy to address significant health challenges and achieve its ambitious sales goals.

The launch of Blujepa is slated for the second half of this year, marking a significant milestone for GSK.

This approval is also one of five anticipated by the company in 2025, alongside potential expansions for its antibody-drug conjugate Blenrep and asthma medication Nucala, as well as a new launch for the biologic depemokimab.

These developments are crucial for GSK as it seeks to offset revenue declines from expiring patents and meet its increased sales target of over £40 billion (US$50 million) by 2031.

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