UTILITY Receives Qualified Infectious Disease Product Designation for Uncomplicated Urinary Tract Infections from US FDA
July 16 2018 - 2:00AM
Business Wire
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 UTILITY, 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.”
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.
About mecillinam/pivmecillinam
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.
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UTILITY therapeuticsMark Beards, +44 203 930
9665CEOinfo@utilitytherapeutics.comorConsilium Strategic
CommunicationsMary-Jane Elliott, David Daley, Ivar Milligan,
Chris Welsh, +44 20 3709 5700utility@consilium-comms.com