WASHINGTON (dpa-AFX) - 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, according to FDA.
The federal agency warned patients not to 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.
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