GSK breaks 30-year drought with new oral antibiotic for UTIs

U.K. – GSK has made history by gaining FDA approval for Blujepa (gepotidacin), the first oral antibiotic with a new mechanism of action for uncomplicated urinary tract infections (uUTIs) in nearly 30 years.

The approval followed a priority review and marks a significant breakthrough in the fight against antimicrobial resistance (AMR).

Blujepa belongs to a new class of antibiotics called triazaacenaphthylene and is approved for use in adults and children aged 12 and older.

It treats uUTIs caused by various bacteria, including Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.

Its unique dual mechanism of action targets two different type II topoisomerase enzymes, which disrupts DNA replication and makes it harder for bacteria to develop resistance.

Antimicrobial resistance is a growing global crisis, causing an estimated 1.5 million deaths each year.

If left unchecked, some estimates suggest AMR could claim 10 million lives annually by 2050. The arrival of Blujepa offers hope in a field that has seen few new antibiotic classes reach the market over the last few decades.

GSK’s Chief Scientific Officer Tony Wood highlighted the importance of the approval, saying, “The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women.”

He noted that around 16 million women in the US are diagnosed with uUTIs annually. As drug-resistant bacteria become more common, the need for new treatments is more urgent than ever.

Gepotidacin’s approval was based on positive results from two clinical trials, EAGLE-2 and EAGLE-3, which demonstrated that the antibiotic was as effective as nitrofurantoin, the standard treatment for uUTIs. The trials showed numerically superior therapeutic success rates with Blujepa.

Rising resistance to existing uUTI treatments has led to failure rates of 10% to 18% with first-line therapies. When left untreated or improperly managed, uUTIs can cause serious complications such as kidney inflammation (pyelonephritis) and sepsis.

“We are proud to have developed Blujepa, the first in a new class of oral antibiotics for uUTIs in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments,” said Wood.

GSK is also developing gepotidacin for other bacterial infections, including uncomplicated urogenital gonorrhea.

In the EAGLE-1 trial last year, it was shown to be as effective as the standard treatment of an intramuscular injection of ceftriaxone and oral azithromycin.

GSK is one of the few major pharmaceutical companies still actively investing in antibiotic research and development.

Many companies have abandoned this area due to difficulties in generating sufficient returns on investment, especially since antibiotics are often reserved for use when other treatments fail.

Despite these challenges, GSK is optimistic about Blujepa’s commercial potential. Along with two other anti-infective candidates in its pipeline – the oral carbapenem antibiotic tebipenem and the antifungal Brexafemme (ibrexafungerp) – the company predicts annual peak sales could exceed £2 billion (US $ 2.59 billion).

GSK plans to launch Blujepa in the US during the second half of this year.