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By Sneha S K and Unnamalai L
October 25, 202410:39 PM GMT+7
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo Purchase Licensing Rights
Oct 25 (Reuters) - The U.S. Food and Drug Administration has approved Iterum Therapeutics' (ITRM.O), opens new tab 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.
Reporting by Unnamalai L and Sneha S K in Bengaluru; Editing by Devika Syamnath
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