Let’s face it, UTIs are the worst. They’re painful, irritating, and just when you think you’ve kicked them to the curb, BAM, they’re back! But there’s finally some good news for those battling these relentless infections.
A pioneering new antibiotic has entered the fight against some of the most stubborn UTIs around. This month, the FDA greenlit Iterum Therapeutics’ Orlynvah for treating specific types of UTIs that don’t respond to conventional treatments.
UTIs are incredibly common, particularly among women. Around 60% of women in the US will experience at least one uncomplicated UTI in their lifetime. While UTIs used to be easily vanquished with a simple course of antibiotics, many present-day infections are resistant to common first-line drugs. This makes early treatment trickier and increases the chances of recurrent infections. The scientific community has been tirelessly searching for new antibiotics capable of tackling these resistant bugs.
Orlynvah marks a significant breakthrough. This novel drug combines sulopenem etzadroxil, a member of the powerful penem class of antibiotics, with probenecid, a compound that extends the time antibiotics remain active in the body. Penems have shown great promise against a wide range of resistant bacteria, and Orlynvah is the first oral penem to receive FDA approval in the United States.
This game-changer is specifically approved for treating uncomplicated UTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis bacteria. Importantly, Orlynvah is reserved for individuals with limited or no other oral antibiotic options, such as those with infections that haven’t responded to previous treatments or those exhibiting clear resistance to other drugs through testing. The FDA’s approval was based on two Phase III trials which demonstrated Orlynvah’s effectiveness, matching or surpassing that of standard antibiotics for uncomplicated UTIs, including resistant cases.
“The FDA approval of sulopenem is fantastic news for healthcare providers and patients who have been longing for a new option to treat at-risk patients suffering from UTIs,” said Dr. Marjorie Golden, an infectious disease specialist at Yale New Haven Hospital and a key participant in the drug’s clinical research. “Based on the comprehensive clinical data, sulopenem has the potential to be a vital treatment option for use in outpatient settings.”
While Orlynvah holds immense value for doctors and patients, it’s not a universal UTI solution. The drug didn’t pass clinical trials for complicated UTIs or complicated intra-abdominal infections. Like many newer antibiotics, its use will be carefully monitored to minimize the development of antibiotic-resistant bacterial strains.
