SILVER
SPRING, Md., April 24,
2024 /PRNewswire/ -- Today, the U.S. Food and Drug
Administration approved Pivya (pivmecillinam) tablets for the
treatment of female adults with uncomplicated urinary tract
infections (UTIs) caused by susceptible isolates of Escherichia
coli, Proteus mirabilis and Staphylococcus
saprophyticus.
"Uncomplicated UTIs are a very common condition impacting
women and one of the most frequent reasons for antibiotic use,"
said Peter Kim, M.D., M.S., director
of the Division of Anti-Infectives in the FDA's Center for Drug
Evaluation and Research. "The FDA is committed to fostering new
antibiotic availability when they prove to be safe and effective,
and Pivya will provide an additional treatment option for
uncomplicated UTIs."
Uncomplicated UTIs are bacterial infections of the bladder in
females with no structural abnormalities of their urinary tract.
Approximately one-half of all women experience at least one UTI in
their lifetime.
Pivya's efficacy in treating females 18 years of age or older
with uncomplicated UTIs was assessed in three controlled clinical
trials comparing different Pivya dosing regimens to placebo, to
another oral antibacterial drug and to ibuprofen (an
anti-inflammatory drug). The primary measure of efficacy for the
three trials was the composite response rate, which included
clinical cure (resolution of the symptoms of the uncomplicated UTI
that were present in patients at trial entry and no new symptoms)
and microbiological response (demonstration that the bacteria
cultured from patients' urine at trial entry was reduced). The
composite response rate was assessed approximately 8 to 14 days
after patients were enrolled into the studies. In the clinical
trial comparing Pivya to placebo, 62% of the 137 subjects who
received Pivya achieved the composite response compared to 10% of
the 134 who received placebo. In the clinical trial comparing Pivya
to another oral antibacterial drug, 72% of the 127 subjects who
received Pivya achieved composite response compared to 76% of the
132 who received the comparator drug. In the clinical
trial comparing Pivya to ibuprofen, 66% of the 105 subjects
who received Pivya achieved composite response compared to 22% of
the 119 who received ibuprofen.
The most common side effects of Pivya included nausea and
diarrhea.
Patients should not use Pivya if they have a known history of
severe hypersensitivity to Pivya or other beta-lactam antibacterial
drugs. Patients should also not use Pivya if they have primary or
secondary carnitine deficiency resulting from inherited disorders
of mitochondrial fatty acid oxidation and carnitine metabolism, or
if they are suffering from porphyria.
Pivya comes with certain warnings and precautions such as
hypersensitivity reactions, severe cutaneous adverse reactions,
carnitine depletion, Clostridioides difficile-associated
diarrhea and interference with a newborn screening test for
isovaleric acidemia, a rare metabolic disorder.
Pivya was granted Priority Review and Qualified Infectious
Disease Product designations for this indication.
The FDA granted the approval of Pivya to UTILITY therapeutics
Ltd.
Additional resources:
- Antimicrobial Resistance Information from FDA
Media Contact: Chanapa Tantibanchachai,
202-384-2219
Consumer Inquiries: Email, 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, radiation-emitting electronic products, and for
regulating tobacco products.
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SOURCE U.S. Food and Drug Administration