GlaxoSmithKline (GSK) has brought a new era to urinary tract infection (UTI) treatment with its antibiotic Blujepa, the first oral antibiotic in nearly 30 years. The FDA has cleared Blujepa for treating uncomplicated UTIs caused by specific bacteria in women aged 12 and older.
According to GSK, more than half of women will experience a UTI in their lifetime, making this new option crucial. The company tested Blujepa in phase 3 trials, showing it to be noninferior to the standard treatment nitrofurantoin in terms of therapeutic success.
Blujepa differs from other options due to its unique mechanism of action and potential to combat antimicrobial resistance, a growing threat in UTI treatments. The antibiotic specifically targets E. coli bacteria, which cause most UTI infections, and does not exhibit the same level of resistance as other drugs.
GSK plans to launch Blujepa in the second half of this year, aiming to capitalize on its unique benefits. The company is also testing the drug for gonorrhea treatment and has another option in development for complicated UTIs.
This new approval marks a significant milestone for GSK’s infectious disease pipeline, which it touts as one of the largest and most diverse in the industry. With this achievement, the company aims to meet its 2031 sales goal of over $50 billion.
Source: https://www.fiercepharma.com/pharma/gsk-ushers-new-uti-antibiotic-fda-nod-first-class-blujepa