By Sneha S K and Unnamalai L
(Reuters) -The U.S. Food and Drug Administration has approved Iterum Therapeutics’ oral antibiotic to treat certain types of bacterial urinary tract infections (UTI) in adult women, the health regulator said on Friday.
The drug, Orlynvah, has been approved to treat uncomplicated UTIs in women who have limited oral antibacterial treatment options or none at all. UTI is a common bacterial infection of the bladder that mostly affects women with normal anatomy of the urinary tract.
Half of all women in the U.S. experience at least one uncomplicated UTI during their lifetime, according to the company. Despite the approval of several antibiotics, some patients may have limited options due to side effects and a rise in drug-resistant bacteria.
The company anticipates a commercial launch for Orlynvah around mid-2025, CEO Corey Fishman told Reuters on Thursday.
The regulator’s decision comes after it declined to approve the drug in 2021, calling for more data. The company subsequently re-submitted its application after late-stage trials showed the drug was well-tolerated with no safety issues identified.
The FDA last month held a meeting of outside advisors to discuss the relative risks or benefits of using the drug chemically known as sulopenem.
The advisors to the FDA had said there could be a high risk of its off-label use, with significant community and individual risk in the form of increasing antimicrobial resistance against carbapenems, the class of antibiotics to which sulopenem belongs.
The company said in January it was looking to sell or license the rights to the treatment.
CEO Fishman told Reuters on Thursday the company will renew partnership talks if it gets approval for Orlynvah.
“Our belief is that any pharma company mid-size, larger, that has products that are already being prescribed, in large part by those doctors, would be a potential good match for sulopenem,” said Fishman.
(Reporting by Unnamalai L and Sneha S K in Bengaluru; Editing by Devika Syamnath)
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