UTILITY Therapeutics Preparing NDA Submission

15 June 2021

Utility Therapeutics

  • Pivmecillinam NDA submission targeted for fourth quarter of 2021

LONDON, ENGLAND / ACCESSWIRE / June 15, 2021 / UTILITY therapeutics Ltd., a biotechnology company focused on the development and commercialization of two European-approved antibiotics for the treatment of urinary tract infections (UTIs) in the U.S., provided a business update today. The company is preparing a New Drug Application (NDA) with the U.S. FDA for pivmecillinam for the treatment of uncomplicated UTIs. The NDA submission is currently planned for fourth quarter of 2021.

“We recently completed a pre-NDA meeting with the FDA for pivmecillinam and received feedback indicating that the proposed format and content of the NDA data package that we are preparing supports the submission,” stated Thomas Hadley, President and Chief Commercial Officer of UTILITY therapeutics. “In anticipation of our NDA submission, we have also taken the requisite steps to initiate the transition to a commercial-stage organization in support of a potential product launch in 2022.”

About UTILITY therapeutics Ltd.

UTILITY has exclusive U.S. commercial rights to two European-approved antibiotics, pivmecillinam and mecillinam, for the treatment of urinary tract infections (UTI). Pivmecillinam is an oral prodrug of mecillinam that is being developed for uncomplicated UTI (uUTI), and it has a unique mechanism of action for infections caused by Gram-negative bacteria, including extended-spectrum beta-lactamases. Mecillinam, an intravenous (IV) formulation, is being developed as a first-line therapy for complicated UTI (cUTI) in the hospital setting.

UTILITY has received the FDA’s qualified infectious disease product (QIDP) designation for pivmecillinam for the treatment of uUTI, and IV mecillinam followed by oral pivmecillinam as step-down, carbapenem-sparing therapy for cUTI. This therapeutic regimen allows patients to complete their treatment outside of hospital and reduces the economic burden of cUTI to both patients and payers. The FDA’s QIDP designation is for antibacterial and antifungal drug candidates intended to treat serious or life-threatening infections, and it provides an additional five years of market exclusivity and potential Priority Review.

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Tom Hadley
President and Chief Commercial Officer
Tel: +1 (973) 224-7272

SOURCE: Utility Therapeutics Ltd.

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