Iterum Therapeutics expands ORLYNVAH coverage, receives new patent

Iterum Therapeutics plc (NASDAQ: ITRM) announced a rebate agreement with one of the top three Medicare Part D Pharmacy Benefit Managers, expanding potential coverage for its antibiotic ORLYNVAH to more than 3.5 million lives beginning as early as this quarter.

The Dublin and Chicago-based company received a U.S. patent numbered 12,544,337 covering a bilayer tablet comprising sulopenem etzadroxil and probenecid. The patent, titled "Combinations of Beta-Lactam Compounds and Probenecid and Uses Thereof," is projected to expire in December 2039 and covers methods of treating diseases including uncomplicated urinary tract infections.

The Food and Drug Administration responded to Iterum's request regarding the use of ORLYNVAH as step-down therapy for complicated urinary tract infections. The FDA determined that the company would need to provide substantial evidence of effectiveness from an adequate clinical trial in a supplemental new drug application to support the proposed indication. The agency recommended Iterum request a Type C meeting to discuss the design and endpoints of any proposed clinical investigation.

ORLYNVAH is approved for treating uncomplicated urinary tract infections caused by specific microorganisms in adult women with limited or no alternative oral antibacterial treatment options. The oral antibiotic has demonstrated activity against bacteria resistant to other antibiotics, according to the company.

Iterum now has signed rebate agreements with all three top Medicare Part D Pharmacy Benefit Managers. The new patent would bring the total number of U.S. patents listed in the FDA's Orange Book for the company to five if added.

Information in this article is based on a company press release.

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