On Friday, the U.S. Food and Drug Administration announced that Iterum Therapeutics (ITRM.O) has received approval for a new oral antibiotic tab to treat certain bacterial UTIs in adult females.
For women who have few or no options for oral antibiotic treatment for uncomplicated UTIs, Orlynvah has been approved. The majority of women with normal urinary tract anatomy are susceptible to UTIs, a common bacterial infection of the bladder.
According to the company, half of American women will at some point in their lives get at least one simple UTI. Despite the fact that many antibiotics have been approved, adverse effects and the emergence of drug-resistant bacteria may limit the options available to certain individuals.
According to CEO Corey Fishman, the company expects Orlynvah to go on sale in the middle of 2025, he told Reuters on Thursday. The decision was made by the regulator after it refused to authorize the medication in 2021, citing a lack of data. After late-stage trials revealed the medicine was well tolerated and no safety concerns were found, the company later resubmitted their application.
To discuss the relative risks or benefits of using the medication chemically known as sulopenem, the FDA convened a conference of independent advisors last month. Sulopenem’s off-label usage may pose a serious risk to the community and to individuals due to the rise in antimicrobial resistance against carbapenems, the class of antibiotics to which it belongs, according to the FDA’s experts. In January, the business announced that it was exploring to sell or license the treatment’s rights.
If Orlynvah is approved, CEO Fishman told Reuters on Thursday that the company will extend collaboration negotiations. “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,” Fishman stated.
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