UTILITY receives Qualified Infectious Disease Product designation for uncomplicated urinary tract infections from US FDA
London, UK. 16 July 2018 – UTILITY therapeutics Ltd (“UTILITY” or “the Company”), a pharmaceutical company focused on developing and commercialising antibiotics in the US, today announced that the US Food and Drug Administration (FDA) has designated pivmecillinam as a Qualified Infectious Disease Product (QIDP) for the indication of uncomplicated urinary tract infection (uUTI).
This follows the granting of a QIPD designation to pivmecillinam and mecillinam earlier this year for the indication of complicated urinary tract infection (cUTI).
The QIDP designation provides certain incentives for the development of antibacterial and antifungal drug products that treat serious or life-threatening infections, which may include priority review, and a five-year extension of market exclusivity.
“Uncomplicated UTIs are extremely common infections, and present a significant burden on patients and health systems—especially if caused by multidrug-resistant Gram-negative pathogens”, said Paul Eckburg, MD, Acting Chief Medical Officer of UTILITY. “If not treated effectively with appropriate oral antibiotics, these infections may lead to hospitalisation or require IV therapy.”
“This is an exciting development for UTILTY, demonstrating our commitment to help patients in the US by providing a new treatment option for uUTI” said Mark Beards, Chief Executive Officer of UTILITY. “There remains a huge need for alternative uUTI treatment options. UTIs are one of the most common clinical bacterial infections in women, accounting for nearly 25% of all infections, but resistance to currently available treatments is growing. With pivmecillinam we have the opportunity to provide a new first-line treatment for patients with uUTI in the US, whilst preserving the effectiveness of second-line therapies which should be held in reserve.”
For more information, please contact:
Mark Beards, CEO
+44 203 930 9665
Consilium Strategic Communications
Mary-Jane Elliott, David Daley, Ivar Milligan, Chris Welsh,
+44 20 3709 5700
Notes for editors:
About UTILITY therapeutics Limited
UTILITY therapeutics is focused on developing and commercialising antibiotics in the US, to address the significant threat faced by healthcare systems and patients from multi-drug resistant bacterial infections. The World Health Organisation has stated that antibiotic resistance is one of the biggest threats to global health, food security, and development today.
Mecillinam is a member of the penicillin subgroup of the β-lactam antibiotic class, a widely used class of antibacterial agents for the treatment of multiple serious infection types. It is available outside the US in both IV and oral formulations; the oral formulation contains the prodrug pivmecillinam HCl, while the IV formulation contains the active drug mecillinam.
Pivmecillinam and mecillinam have excellent safety and efficacy profiles for oral and parenteral use, respectively, through extensive clinical usage over 40 years. Currently, pivmecillinam tablets are approved in Europe, some Asiatic countries and some African countries for the treatment of uUTI (ie, acute uncomplicated cystitis) caused by bacteria susceptible to mecillinam.
Pivmecillinam is featured in the Infectious Diseases Society of America guidelines as a first-line therapy for uncomplicated urinary tract infections, despite it not yet being available in the US.