New Antibiotic Blujepa Gains FDA Approval for UTI Treatment

Prime Highlights

The U.S. FDA has approved GSK’s new antibiotic, Blujepa, for the treatment of women aged 12 years and older with uncomplicated urinary tract infections (UTIs).
Blujepa compared favorably to standard therapy, nitrofurantoin, in end-stage clinical trials.

Key Facts

Blujepa, or gepotidacin, is active against well-documented UTI-germinating bacteria, resistant as well as susceptible.
GSK plans to launch Blujepa in the U.S. later this year, price TBD.

Key Background

GSK’s new drug Blujepa was approved by the FDA to be used to treat uncomplicated UTIs in girls and women aged 12 years and older. They are usually encountered in healthy individuals and are usually caused by microorganisms such as Escherichia coli (E. coli). GSK anticipates marketing Blujepa sometime this year in the US, but they haven’t listed prices.

Blujepa or gepotidacin is based on a new mechanism as opposed to most of the existing antibiotics. This feature makes it potent against resistant bacterial strains. Additionally, because Blujepa requires mutations in two different enzymes of bacteria to be resistant, bacterial resistance in the long term is less probable.

Antimicrobial resistance poses an increasing danger to public health, and there are over 2.8 million antibiotic-resistant infections each year in the U.S., reports the CDC. The approval of Blujepa gives us a new important weapon in combat against this menace.

The FDA relied on two phase III trials to compare Blujepa to nitrofurantoin, which was one of the most popular antibiotics of the 1950s. At one trial, researchers discovered that 58.5% of patients who received Blujepa reported complete eradication of the infection, versus 43.6% of patients on nitrofurantoin. This is increased efficacy on the part of Blujepa.

GSK supported some development of Blujepa with U.S. government grants, emphasizing common missions in combatting antibiotic resistance. The approval is one part of GSK’s larger strategy to expand its infectious disease pipeline, with revenue headwinds in the future due to pending patent expirations on existing drugs. Blujepa and other pipeline treatments are projected by the company to generate over $2.59 billion in peak sales per year.

This clearance follows last month’s approval by the FDA of Iterum Therapeutics’ second UTI treatment, Orlynvah. Adding Blujepa further increases the treatment options available for the treatment of UTIs, particularly in the current era of antibiotic resistance.