The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation to mecillinam (IV formulation) and pivmecillinam (oral prodrug) for the treatment of complicated urinary tract infections (cUTI).

Mecillinam is a beta-lactam antibiotic with a novel site of action which is specific and highly active against Gram-negative bacteria. Clinical trials of both mecillinam and its prodrug pivmecillinam have shown that the drug is both safe and effective in both IV and oral form; both formulations are currently available for use outside of the US. Despite being unavailable the in US, pivmecillinam is featured in the Infectious Disease Society of America guidelines as a first line treatment for uncomplicated UTI.

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“Increasing antimicrobial resistance in the US is significantly limiting the number of IV/oral treatment options available to treat cUTI caused by multidrug-resistant (MDR) pathogens,” said Paul Eckburg, MD, Acting Chief Medical Officer of UTILITY. “Mecillinam/pivmecillinam is an IV/oral carbapenem-sparing option with a good safety and efficacy profile against these MDR pathogens after decades of use outside the US ― it addresses an important unmet need in the US”

Receiving QIDP designation provides manufacturers with certain incentives such as priority review and a 5-year extension of market exclusivity. “QIDP designation gives us the confidence to move forward to the next step for mecillinam in the US, to achieve an IND to start clinical development,” said Mark Beards, Chief Executive Officer of UTILITY.

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